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Effect of APRV vs. LTV on Right Heart Function in ARDS Patients: a Single-center Randomized Controlled Study

Primary Purpose

Right Heart Failure, Mechanical Ventilation, Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Airway pressure release ventilation
low tidal volume
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Patients who meet the 2012 Berlin ARDS diagnostic criteria and perform invasive mechanical ventilation 2, PEEP≥5cmH2O, oxygenation index ≤200mmHg 3. Tracheal intubation and mechanical ventilation were performed for less than 48h at the time of inclusion 4. Age ≥18 years and ≤80 years Exclusion Criteria: 1.abdominal pressure≥20mmHg 2.BMI≥35kg/m2; 3. pregnant and lactating women 4.expected duration of invasive mechanical ventilation < 72 hours 5. neuromuscular diseases known to require prolonged mechanical ventilation 6.severe chronic obstructive pulmonary disease, severe asthma, Interstitial lung disease 7.intracranial hypertension, 8.pulmonary bullae or pneumothorax, subcutaneous emphysema, or mediastinal emphysema, 9.extracorporeal membrane oxygenation or prone position ventilation on admission to the ICU 10. uncorrected shock of various types and refractory shock 11.pulmonary embolism 12.severe cardiac dysfunction (New York Heart Association class III or IV). Acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary diseases, cardiogenic shock or after major cardiac surgery 13.poor cardiac sound window, unable to obtain cardiac ultrasound images 14.no informed consent was signed

Sites / Locations

  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

APRV group

LTV group

Arm Description

In APRV group, ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate.

The ARDSnet method was used for LTV group mechanical ventilation, and the tidal volume was set according to 4-8ml/kg, so that the Pplat was <30cmH2O

Outcomes

Primary Outcome Measures

Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h.Abnormal findings on any of the following ultrasound measures can be considered as right ventricular dysfunction, including: right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD)>1.0, right ventricular fractional area change(RVFAC)<35%,tricuspid annular plane systolic excursion(TAPSE)<17mm,Systolic S'velocity of tricuspid annulus <9.5 cm/s by TDI

Secondary Outcome Measures

Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 48h
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h.Abnormal findings on any of the following ultrasound measures can be considered as right ventricular dysfunction, including: right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD)>1.0, right ventricular fractional area change(FAC)<35%,tricuspid annular plane systolic excursion(TAPSE)<17mm,Systolic S'velocity of tricuspid annulus <9.5 cm/s by TDI
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 72h
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h.Abnormal findings on any of the following ultrasound measures can be considered as right ventricular dysfunction, including: right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD)>1.0, right ventricular fractional area change(FAC)<35%,tricuspid annular plane systolic excursion(TAPSE)<17mm,Systolic S'velocity of tricuspid annulus <9.5 cm/s by TDI
Values of tricuspid annular plane systolic excursion at 24th hour
Tricuspid annular plane systolic excursion(TAPSE) was measured by echocardiography in the apical four-chamber view, using M mode measurements, with the sampling line aligned to the tricuspid annulus.
Values of tricuspid annular plane systolic excursion at 48th hour
Tricuspid annular plane systolic excursion(TAPSE) was measured by echocardiography in the apical four-chamber view, using M mode measurements, with the sampling line aligned to the tricuspid annulus.
Values of tricuspid annular plane systolic excursion at 72th hour
Tricuspid annular plane systolic excursion(TAPSE) was measured by echocardiography in the apical four-chamber view, using M mode measurements, with the sampling line aligned to the tricuspid annulus.
Values of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD) at 24th hour
The maximum transverse diameter of the right/left ventricular inflow tract near the basal 1/3 was measured in the apical four-chamber view
Values of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD) at 48th hour
The maximum transverse diameter of the right/left ventricular inflow tract near the basal 1/3 was measured in the apical four-chamber view
Values of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD) at 72th hour
The maximum transverse diameter of the right/left ventricular inflow tract near the basal 1/3 was measured in the apical four-chamber view
Values of right ventricular fractional area change(RVFAC) at 24th hour
RVFAC = (end-diastolic area - end-systolic area)/end-diastolic area ×100%.The right ventricle is shown in the apical four-chamber cardiac view.
Values of right ventricular fractional area change(RVFAC) at 48th hour
RVFAC = (end-diastolic area - end-systolic area)/end-diastolic area ×100%.The right ventricle is shown in the apical four-chamber cardiac view.
Values of right ventricular fractional area change(RVFAC) at 72th hour
RVFAC = (end-diastolic area - end-systolic area)/end-diastolic area ×100%.The right ventricle is shown in the apical four-chamber cardiac view.
Values of Systolic S'velocity of tricuspid annulus by at 24th, 48th and 72th hour
Tissue Doppler sampling volume is placed in the middle of the right ventricular tricuspid annulus or basal segment of the right ventricular free wall to measure systolic velocity S'.
Values of hemodynamic measures at 24th, 48th and 72th hour
hemodynamic measures including: heart rate, mean arterial pressure,central venous pressure,Dose of vasoactive agents accumulated over 24 hours,cumulative fluid balance over 24 hours.
Values of respiratory mechanics parameters at 24th, 48th and 72th hour
Respiratory mechanics parameters including Peak pressure, Plateau pressure,Driving pressure,Respiratory system compliance and Airway resistance are measured by using routine procedures
28-day mortality
28-day mortality after study entry
in hospital mortality
in hospital mortality after study entry
28 days of ventilator free days
28 days of ventilator free days after study entry
Values of arterial partial pressure of oxygen/fraction of inspired oxygen at 24th, 48th and 72th hour
arterial partial pressure of oxygen/fraction of inspired oxygen are measured at 24th, 48th and 72th hour after inclusion
Values of arterial partial pressure of carbon dioxide at 24th, 48th and 72th hour
arterial partial pressure of carbon dioxide are measured at 24th, 48th and 72th hour after inclusion
ventilation ratio at 24th, 48th and 72th hour
VR=[minute ventilation ×PaCO2]/[predicted body weight ×100×37.5]
Incidence prone position ventilation during hospitalization
Incidence of prone position ventilation during hospitalization after study entry
ventilator settings at 24th, 48th and 72th hour
ventilator settings including minute ventilation, Fraction of inspired oxygen, tidal volume, positive end-expiratory pressure, respiratory rate, mean airway pressure
Velocity-time integral of left ventricular outflow tract at 24th, 48th and 72th hour
Velocity-time integral(Vti) of left ventricular outflow tract are measured at the apical five-chamber heart view. The sampling volume was placed in the left ventricular outflow tract, below the aortic valve, in pulsed Doppler mode with a window width of 2-4mm. The velocity time integral (VTI) image of aortic blood flow can be obtained by placing the sampling volume below the aortic valve orifice , adjusting the probe so that the direction of blood flow is as parallel as possible to the sampling line, and selecting the pulsed Doppler mode (PW)
Stroke volume at 24th, 48th and 72th hour
Stroke volume(SV)=15.VTI×π(D/2)*(D/2), D=Left ventricular outflow tract diameter(LVOT diameter)
cardiac output at 24th, 48th and 72th hour
cardiac output(CO)=SV*HR
Velocity-time integral of right ventricular outflow tract at 24th, 48th and 72th hour
Velocity-time integral(Vti) of right ventricular outflow tract are measured at the view of the right ventricular outflow tract. The sampling volume was placed in the right ventricular outflow tract, below the aortic valve, in pulsed Doppler mode with a window width of 2-4mm. The velocity time integral (VTI) image of aortic blood flow can be obtained by placing the sampling volume below the aortic valve orifice , adjusting the probe so that the direction of blood flow is as parallel as possible to the sampling line, and selecting the pulsed Doppler mode (PW)
Tricuspid annular diameter
Tricuspid annular diameters are measured at the apical four-chamber heart view
The velocity of tricuspid regurgitation
The velocity of tricuspid regurgitation are measured at the apical four-chamber heart view.The CW Doppler sampling line was placed at the tricuspid valve orifice.
Length of hospital stay
hospital stay after hospital entry
Length of ICU stay
hospital stay after ICU entry
Incidence of tracheotomy
Incidence of tracheotomy during hospitalization after study entry

Full Information

First Posted
June 19, 2023
Last Updated
June 27, 2023
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05922631
Brief Title
Effect of APRV vs. LTV on Right Heart Function in ARDS Patients: a Single-center Randomized Controlled Study
Official Title
Effect of Airway Pressure Release Ventilation vs. Low Tidal Volume Ventilation on Right Heart Function in Acute Respiratory Distress Syndrome Patients: a Single-center Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute Respiratory Distress Syndrome (ARDS) is often complicated by Right Ventricular Dysfunction (RVD), and the incidence can be as high as 64%. The mechanism includes pulmonary vascular dysfunction and right heart systolic dysfunction. Pulmonary vascular dysfunction includes acute vascular inflammation, pulmonary vascular edema, thrombosis and pulmonary vascular remodeling. Alveolar collapse and over distension can also lead to increased pulmonary vascular resistance, Preventing the development of acute cor pulmonale in patients with acute respiratory distress. ARDS patients with RVD have a worse prognosis and a significantly increased risk of death, which is an independent risk factor for death in ARDS patients. Therefore, implementing a right heart-protective mechanical ventilation strategy may reduce the incidence of RVD. APRV is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure, which can effectively improve oxygenation and reduce ventilator-associated lung injury. However, its effect on right ventricular function is still controversial. Low tidal volume (LTV) is a mechanical ventilation strategy widely used in ARDS patients. Meta-analysis results showed that compared with LTV, APRV improved oxygenation more significantly, reduced the time of mechanical ventilation, and even had a tendency to improve the mortality of ARDS patients However, randomized controlled studies have shown that compared with LTV, APRV improves oxygenation more significantly and also increases the mean airway pressure. Therefore, some scholars speculate that APRV may increase the intrathoracic pressure, pulmonary circulatory resistance, and the risk of right heart dysfunction but this speculation is not supported by clinical research evidence. In addition, APRV may improve right ventricular function by correcting hypoxia and hypercapnia, promoting lung recruitment and reducing pulmonary circulation resistance. Therefore, it is very important to clarify this effect for whether APRV can be safely used and popularized in clinic.we aim to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS, pulmonary circulatory resistance (PVR) right ventricular-pulmonary artery coupling (RV-PA coupling), and pulmonary vascular resistance (PVR).
Detailed Description
Acute Respiratory DistressSyndrome (ARDS) is often complicated by Right Ventricular Dysfunction (RVD), and the incidence can be as high as 64%. The mechanism includes pulmonary vascular dysfunction and right heart systolic dysfunction. Pulmonary vascular dysfunction includes acute vascular inflammation, pulmonary vascular edema, thrombosis and pulmonary vascular remodeling. Alveolar collapse and alveolar overdistension can also lead to increased pulmonary vascular resistance, Preventing the development of acute cor pulmonale in patients with acute respiratory distress. ARDS patients with RVD have a worse prognosis and a significantly increased risk of death, which is an independent risk factor for death in ARDS patients [2-4]. Therefore, implementing a right heart-protective mechanical ventilation strategy may reduce the incidence of RVD. Mechanical ventilation is the main treatment for moderate to severe ARDS. Mechanical ventilation promotes lung recruitment and reduces mechanical compression of pulmonary vessels between alveoli and alveolar walls. In addition, mechanical ventilation corrected hypoxemia and hypercapnia, thereby reducing reactive pulmonary vasoconstriction. All of the above can reduce pulmonary circulation resistance and right ventricular afterload, thereby improving right ventricular function in patients with ARDS. However, if hyperventilation occurs, it will increase the mechanical compression of pulmonary vessels on the alveolar wall, increase the intrathoracic pressure, and increase the afterload of the right heart, which will adversely affect the function of the right heart. There are a variety of ventilation strategies for patients with ARDS in clinical practice, but which mechanical ventilation has the protective function of right heart or has little effect on right heart function, so far there is a lack of relevant research reports. Airway pressure release ventilation (APRV) is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure, which can effectively improve oxygenation and reduce ventilator-associated lung injury. However, its effect on right ventricular function is still controversial, so its clinical application is not popular, and it is only used as one of the salvage treatments for ARDS patients. Low tidal volume (LTV) is a mechanical ventilation strategy widely used in ARDS patients, but it does not further reduce mortality in patients with moderate to severe ARDS. Meta-analysis results showed that compared with LTV, APRV improved oxygenation more significantly, reduced the time of mechanical ventilation, and even had a tendency to improve the mortality of ARDS patients [7]. However, randomized controlled studies have shown that compared with LTV, APRV improves oxygenation more significantly and also increases the mean airway pressure [8]. Therefore, some scholars speculate that APRV may increase the intrathoracic pressure, pulmonary circulatory resistance, and the risk of right heart dysfunction , but this speculation is not supported by clinical research evidence. In addition, the results of animal experiments suggest that APRV improves oxygenation, promotes lung recruitment, and improves the heterogeneity of lung lesions in ARDS, without causing lung hyperventilation, suggesting that APRV may not increase pulmonary circulatory resistance. In addition, APRV may improve right ventricular function by correcting hypoxia and hypercapnia, promoting lung recruitment and reducing pulmonary circulation resistance. Therefore, the impact of APRV on right ventricular function is still unclear, and it is very important to clarify this effect for whether APRV can be safely used and popularized in clinic. Therefore, our research group conducted a prospective observational study, "The effect of APRV on right ventricular function evaluated by Transthoracic Echocardiography, [2022] Lun Lun Zi (0075)". The study results suggested that APRV improved lung perfusion in ARDS patients while effectively improving oxygenation and promoting lung recruitment. The incidence of RVD was not increased, and there was no hemodynamic deterioration in ARDS patients. APRV is safe and effective for patients with ARDS. However, the results of a single-arm prospective observational study with a small sample size cannot provide strong evidence for clinical practice. In the previous studies, all the right ventricular function was assessed by transthoracic echocardiography. Due to the limitation of the sound window of transthoracic echocardiography, the right ventricular function of some ARDS patients could not be evaluated. Therefore, this study intends to use transesophageal echocardiography or transthoracic echocardiography to fully evaluate the right ventricular function of all enrolled patients as much as possible, and to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS, pulmonary circulatory resistance (PVR), right ventricular-pulmonary artery coupling (RV-PA coupling), and pulmonary vascular resistance (PVR).Whether there are different effects on hemodynamics and mortality. It is hoped that the results of this study will provide more evidence support for the clinical application of APRV and benefit more ARDS patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Heart Failure, Mechanical Ventilation, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with ARDS who met the inclusion criteria were randomized to APRV or LTV mechanical ventilation. Ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate. For LTV mechanical ventilation, ARDSnet method was used to set the tidal volume according to 4-8ml/kg, so that Pplat<30cmH2O
Masking
Participant
Masking Description
participants are blinded to accept APRV or LTV after inclusion.
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
APRV group
Arm Type
Experimental
Arm Description
In APRV group, ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate.
Arm Title
LTV group
Arm Type
Placebo Comparator
Arm Description
The ARDSnet method was used for LTV group mechanical ventilation, and the tidal volume was set according to 4-8ml/kg, so that the Pplat was <30cmH2O
Intervention Type
Procedure
Intervention Name(s)
Airway pressure release ventilation
Intervention Description
ventilator parameters were set according to the study protocol, P high: Tidal volume (VT) was set at 6ml/kg of ideal body weight, and plateau pressure (Pplat) was measured. Initial Phigh was set at Pplat, usually 20-32 cmH2O. The APRV end-expiratory flow rate was set at 75% of the peak expiratory flow rate.
Intervention Type
Procedure
Intervention Name(s)
low tidal volume
Intervention Description
The ARDSnet method was used for LTV mechanical ventilation, and the tidal volume was set according to 4-8ml/kg, so that the Pplat was <30cmH2O
Primary Outcome Measure Information:
Title
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h
Description
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h.Abnormal findings on any of the following ultrasound measures can be considered as right ventricular dysfunction, including: right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD)>1.0, right ventricular fractional area change(RVFAC)<35%,tricuspid annular plane systolic excursion(TAPSE)<17mm,Systolic S'velocity of tricuspid annulus <9.5 cm/s by TDI
Time Frame
at the time of 24 hours after inclusion
Secondary Outcome Measure Information:
Title
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 48h
Description
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h.Abnormal findings on any of the following ultrasound measures can be considered as right ventricular dysfunction, including: right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD)>1.0, right ventricular fractional area change(FAC)<35%,tricuspid annular plane systolic excursion(TAPSE)<17mm,Systolic S'velocity of tricuspid annulus <9.5 cm/s by TDI
Time Frame
at the time of 48 hours after inclusion
Title
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 72h
Description
Incidence of right heart dysfunction in ARDS patients with APRV or LTV mechanical ventilation for 24h.Abnormal findings on any of the following ultrasound measures can be considered as right ventricular dysfunction, including: right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD)>1.0, right ventricular fractional area change(FAC)<35%,tricuspid annular plane systolic excursion(TAPSE)<17mm,Systolic S'velocity of tricuspid annulus <9.5 cm/s by TDI
Time Frame
at the time of 72 hours after inclusion
Title
Values of tricuspid annular plane systolic excursion at 24th hour
Description
Tricuspid annular plane systolic excursion(TAPSE) was measured by echocardiography in the apical four-chamber view, using M mode measurements, with the sampling line aligned to the tricuspid annulus.
Time Frame
at the time of 24 hours after inclusion
Title
Values of tricuspid annular plane systolic excursion at 48th hour
Description
Tricuspid annular plane systolic excursion(TAPSE) was measured by echocardiography in the apical four-chamber view, using M mode measurements, with the sampling line aligned to the tricuspid annulus.
Time Frame
at the time of 48 hours after inclusion
Title
Values of tricuspid annular plane systolic excursion at 72th hour
Description
Tricuspid annular plane systolic excursion(TAPSE) was measured by echocardiography in the apical four-chamber view, using M mode measurements, with the sampling line aligned to the tricuspid annulus.
Time Frame
at the time of 72 hours after inclusion
Title
Values of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD) at 24th hour
Description
The maximum transverse diameter of the right/left ventricular inflow tract near the basal 1/3 was measured in the apical four-chamber view
Time Frame
at the time of 24 hours after inclusion
Title
Values of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD) at 48th hour
Description
The maximum transverse diameter of the right/left ventricular inflow tract near the basal 1/3 was measured in the apical four-chamber view
Time Frame
at the time of 48 hours after inclusion
Title
Values of right ventricular end-diastolic diameter/left ventricular end-diastolic diameter(RVEDD/LVEDD) at 72th hour
Description
The maximum transverse diameter of the right/left ventricular inflow tract near the basal 1/3 was measured in the apical four-chamber view
Time Frame
at the time of 72 hours after inclusion
Title
Values of right ventricular fractional area change(RVFAC) at 24th hour
Description
RVFAC = (end-diastolic area - end-systolic area)/end-diastolic area ×100%.The right ventricle is shown in the apical four-chamber cardiac view.
Time Frame
at the time of 24 hours after inclusion
Title
Values of right ventricular fractional area change(RVFAC) at 48th hour
Description
RVFAC = (end-diastolic area - end-systolic area)/end-diastolic area ×100%.The right ventricle is shown in the apical four-chamber cardiac view.
Time Frame
at the time of 48 hours after inclusion
Title
Values of right ventricular fractional area change(RVFAC) at 72th hour
Description
RVFAC = (end-diastolic area - end-systolic area)/end-diastolic area ×100%.The right ventricle is shown in the apical four-chamber cardiac view.
Time Frame
at the time of 72 hours after inclusion
Title
Values of Systolic S'velocity of tricuspid annulus by at 24th, 48th and 72th hour
Description
Tissue Doppler sampling volume is placed in the middle of the right ventricular tricuspid annulus or basal segment of the right ventricular free wall to measure systolic velocity S'.
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Values of hemodynamic measures at 24th, 48th and 72th hour
Description
hemodynamic measures including: heart rate, mean arterial pressure,central venous pressure,Dose of vasoactive agents accumulated over 24 hours,cumulative fluid balance over 24 hours.
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Values of respiratory mechanics parameters at 24th, 48th and 72th hour
Description
Respiratory mechanics parameters including Peak pressure, Plateau pressure,Driving pressure,Respiratory system compliance and Airway resistance are measured by using routine procedures
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
28-day mortality
Description
28-day mortality after study entry
Time Frame
Day 28 after study entry
Title
in hospital mortality
Description
in hospital mortality after study entry
Time Frame
Maximum 90-day in-hospital mortality
Title
28 days of ventilator free days
Description
28 days of ventilator free days after study entry
Time Frame
Day 28 after study entry
Title
Values of arterial partial pressure of oxygen/fraction of inspired oxygen at 24th, 48th and 72th hour
Description
arterial partial pressure of oxygen/fraction of inspired oxygen are measured at 24th, 48th and 72th hour after inclusion
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Values of arterial partial pressure of carbon dioxide at 24th, 48th and 72th hour
Description
arterial partial pressure of carbon dioxide are measured at 24th, 48th and 72th hour after inclusion
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
ventilation ratio at 24th, 48th and 72th hour
Description
VR=[minute ventilation ×PaCO2]/[predicted body weight ×100×37.5]
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Incidence prone position ventilation during hospitalization
Description
Incidence of prone position ventilation during hospitalization after study entry
Time Frame
Day 28 after study entry
Title
ventilator settings at 24th, 48th and 72th hour
Description
ventilator settings including minute ventilation, Fraction of inspired oxygen, tidal volume, positive end-expiratory pressure, respiratory rate, mean airway pressure
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Velocity-time integral of left ventricular outflow tract at 24th, 48th and 72th hour
Description
Velocity-time integral(Vti) of left ventricular outflow tract are measured at the apical five-chamber heart view. The sampling volume was placed in the left ventricular outflow tract, below the aortic valve, in pulsed Doppler mode with a window width of 2-4mm. The velocity time integral (VTI) image of aortic blood flow can be obtained by placing the sampling volume below the aortic valve orifice , adjusting the probe so that the direction of blood flow is as parallel as possible to the sampling line, and selecting the pulsed Doppler mode (PW)
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Stroke volume at 24th, 48th and 72th hour
Description
Stroke volume(SV)=15.VTI×π(D/2)*(D/2), D=Left ventricular outflow tract diameter(LVOT diameter)
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
cardiac output at 24th, 48th and 72th hour
Description
cardiac output(CO)=SV*HR
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Velocity-time integral of right ventricular outflow tract at 24th, 48th and 72th hour
Description
Velocity-time integral(Vti) of right ventricular outflow tract are measured at the view of the right ventricular outflow tract. The sampling volume was placed in the right ventricular outflow tract, below the aortic valve, in pulsed Doppler mode with a window width of 2-4mm. The velocity time integral (VTI) image of aortic blood flow can be obtained by placing the sampling volume below the aortic valve orifice , adjusting the probe so that the direction of blood flow is as parallel as possible to the sampling line, and selecting the pulsed Doppler mode (PW)
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Tricuspid annular diameter
Description
Tricuspid annular diameters are measured at the apical four-chamber heart view
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
The velocity of tricuspid regurgitation
Description
The velocity of tricuspid regurgitation are measured at the apical four-chamber heart view.The CW Doppler sampling line was placed at the tricuspid valve orifice.
Time Frame
at the time of 24 hours (h), 48h and 72h after inclusion
Title
Length of hospital stay
Description
hospital stay after hospital entry
Time Frame
Maximum 90-day hospital stay
Title
Length of ICU stay
Description
hospital stay after ICU entry
Time Frame
Maximum 90-day ICU stay
Title
Incidence of tracheotomy
Description
Incidence of tracheotomy during hospitalization after study entry
Time Frame
Day 28 after study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients who meet the 2012 Berlin ARDS diagnostic criteria and perform invasive mechanical ventilation 2, PEEP≥5cmH2O, oxygenation index ≤200mmHg 3. Tracheal intubation and mechanical ventilation were performed for less than 48h at the time of inclusion 4. Age ≥18 years and ≤80 years Exclusion Criteria: 1.abdominal pressure≥20mmHg 2.BMI≥35kg/m2; 3. pregnant and lactating women 4.expected duration of invasive mechanical ventilation < 72 hours 5. neuromuscular diseases known to require prolonged mechanical ventilation 6.severe chronic obstructive pulmonary disease, severe asthma, Interstitial lung disease 7.intracranial hypertension, 8.pulmonary bullae or pneumothorax, subcutaneous emphysema, or mediastinal emphysema, 9.extracorporeal membrane oxygenation or prone position ventilation on admission to the ICU 10. uncorrected shock of various types and refractory shock 11.pulmonary embolism 12.severe cardiac dysfunction (New York Heart Association class III or IV). Acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary diseases, cardiogenic shock or after major cardiac surgery 13.poor cardiac sound window, unable to obtain cardiac ultrasound images 14.no informed consent was signed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojing zou, MD
Phone
027-85351606
Email
want.tofly@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojing zou, MD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongran WU, master
Phone
18627004016
Ext
027-85351607
Email
974528836@qq.com

12. IPD Sharing Statement

Citations:
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Effect of APRV vs. LTV on Right Heart Function in ARDS Patients: a Single-center Randomized Controlled Study

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