Back to resultsEffect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
APRV
LTV
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria: Patients aged ≥18 and ≤80 years; Moderate-to-severe ARDS patients according to the Berlin definition; Endotracheal mechanical ventilation ≤48 h before enrollment; Expected to require continuous invasive mechanical ventilation ≥72 h. Exclusion Criteria: Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc; Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)； Pulmonary interstitial lesions； End-stage of chronic disease, with an expected survival period of <6 months； Body mass index >35 kg/m2; Refractory shock； Intracranial hypertension； Pregnant and parturient woman； Intra-abdominal pressure persisted > 20 mmHg and could not be relieved within 24 hours； Severe thoracic deformity； Severe cardiac dysfunction； Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output； Pulmonary embolism； Extracorporeal membrane oxygenation is needed； Prone positioning was performed before randomization； Patients who have participated in other clinical trials within 30 days； Patients who have not signed informed consent.
Sites / Locations
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
APRV Group
LTV Group
Arm Description
Patients with moderate-to-severe ARDS were supported with APRV.
Patients with moderate-to-severe ARDS were supported with LTV.
Outcomes
Primary Outcome Measures
Lung ventilation/perfusion matching
Lung ventilation/perfusion matching assessed by EIT
Secondary Outcome Measures
Lung ventilation distrubution
Lung ventilation distrubution assessed by EIT
Lung perfusion distrubution
Lung perfusion distrubution assessed by EIT
Dead-space% and shunting%
Lung Dead-space% and shunting% assessed by EIT
Oxygenation index
Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen
Arterial partial pressure of carbon dioxide (PaCO2)
PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.
Static respiratory compliance (Crs)
Crs=tidal volume/driving pressure
Cardiac output
Cardiac output assessed by echocardiography
Right ventricular function
Right ventricular function assessed by echocardiography
Ventilator free days
28d-ventilator free days after randomization
Duration of Intensive care units stay
28d-duration of Intensive care units stay after randomization
Mortality after randomization
28d-all-cause mortality
Full Information
NCT ID
NCT05767125
First Posted
February 16, 2023
Last Updated
March 1, 2023
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05767125
Brief Title
Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS
Official Title
Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
5. Study Description
Brief Summary
Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
APRV Group
Arm Type
Experimental
Arm Description
Patients with moderate-to-severe ARDS were supported with APRV.
Arm Title
LTV Group
Arm Type
Active Comparator
Arm Description
Patients with moderate-to-severe ARDS were supported with LTV.
Intervention Type
Device
Intervention Name(s)
APRV
Intervention Description
Patients with moderate-to-severe ARDS were supported with APRV.
Intervention Type
Device
Intervention Name(s)
LTV
Intervention Description
Patients with moderate-to-severe ARDS were supported with LTV.
Primary Outcome Measure Information:
Title
Lung ventilation/perfusion matching
Description
Lung ventilation/perfusion matching assessed by EIT
Time Frame
24hour
Secondary Outcome Measure Information:
Title
Lung ventilation distrubution
Description
Lung ventilation distrubution assessed by EIT
Time Frame
up to 72hour
Title
Lung perfusion distrubution
Description
Lung perfusion distrubution assessed by EIT
Time Frame
up to 72hour
Title
Dead-space% and shunting%
Description
Lung Dead-space% and shunting% assessed by EIT
Time Frame
up to 72hour
Title
Oxygenation index
Description
Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen
Time Frame
up to 72hour
Title
Arterial partial pressure of carbon dioxide (PaCO2)
Description
PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.
Time Frame
up to 72hour
Title
Static respiratory compliance (Crs)
Description
Crs=tidal volume/driving pressure
Time Frame
up to 72hour
Title
Cardiac output
Description
Cardiac output assessed by echocardiography
Time Frame
up to 72hour
Title
Right ventricular function
Description
Right ventricular function assessed by echocardiography
Time Frame
up to 72hour
Title
Ventilator free days
Description
28d-ventilator free days after randomization
Time Frame
up to 28days
Title
Duration of Intensive care units stay
Description
28d-duration of Intensive care units stay after randomization
Time Frame
up to 28days
Title
Mortality after randomization
Description
28d-all-cause mortality
Time Frame
up to 28days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged ≥18 and ≤80 years;
Moderate-to-severe ARDS patients according to the Berlin definition;
Endotracheal mechanical ventilation ≤48 h before enrollment;
Expected to require continuous invasive mechanical ventilation ≥72 h.
Exclusion Criteria:
Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)；
Pulmonary interstitial lesions；
End-stage of chronic disease, with an expected survival period of <6 months；
Body mass index >35 kg/m2;
Refractory shock；
Intracranial hypertension；
Pregnant and parturient woman；
Intra-abdominal pressure persisted > 20 mmHg and could not be relieved within 24 hours；
Severe thoracic deformity；
Severe cardiac dysfunction；
Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output；
Pulmonary embolism；
Extracorporeal membrane oxygenation is needed；
Prone positioning was performed before randomization；
Patients who have participated in other clinical trials within 30 days；
Patients who have not signed informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojing Zou, prof.
Phone
+862785351606
Email
249126734@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
You Shang, prof.
Phone
+862785351607
Email
you_shanghust@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Shang, prof.
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
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
Learn more about this trial
Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS
We'll reach out to this number within 24 hrs