Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode
Primary Purpose
Acute Lung Injury
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
closed loop
conventional
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury focused on measuring Driving pressure,, Pediatric acute respiratory distress syndrome (PARDS),, Acute lung injury (ALI),, Closed loop ventilation, Pediatric intnsive care unit (PICU)
Eligibility Criteria
Inclusion Criteria:
- All the mechanically ventilated children
- between 1-months and 18-years-old
- without any detectable respiratory effort
- whose clinical condition are not foreseen to change within the next 3 hours
Exclusion Criteria:
- septic shock
- brain death diagnose,
- with a leak equal or more than 40% of the current VT,
- receiving extracorporeal membrane oxygenation (ECMO) or targeted temperature management (TTM),
Sites / Locations
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional
Closed-loop
Arm Description
Outcomes
Primary Outcome Measures
Driving pressure
measured with an occlusion maneuver as the difference between plateau pressure (Pplat) and total PEEP
Secondary Outcome Measures
Tidal Volume (VT)
Integrated from flow measurement
Respiratory rate (RR)
Number of mechanically triggered breaths by the ventilator in 60 seconds
Expiratory time constant (RCexp)
Static compliance (Cstat)
will be derived from volume-flow curve at 75% of the VT and corresponding flow value
Inspiratory time (Ti)
Time used for inspiration during each mechanically triggered breath
Expiratory time (Te)
Time used for expiration during each mechanically triggered breath
pH
the measure of the hydrogen ion (H-) concentration in arterial blood
PaO2
measurement of oxygen pressure in arterial blood
PaCO2
measurement of CO2 pressure in arterial blood
Full Information
NCT ID
NCT04541199
First Posted
August 24, 2020
Last Updated
August 30, 2021
Sponsor
Dr. Behcet Uz Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04541199
Brief Title
Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode
Official Title
Randomized Crossover Trial to Compare Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Behcet Uz Children's Hospital
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
In mechanically ventilated patients, driving pressure (ΔP) assess the strain applied to the respiratory system and is related to ICU mortality. The aim of this randomized cross-over trial was to compare ΔP selected by a closed-loop system and by physician tailored mechanical ventilation mode. Pediatric patients admitted to PICU will be enrolled if they were invasively ventilated without any detectable respiratory effort, hemodynamic instability, or significant leakages. Two 60 minute periods of ventilation determined by randomization in APV-CMV and ASV 1.1 will be compared. Settings were adjusted to reach the same minute ventilation in both modes. ΔP will be calculated as the difference between plateau pressure and total PEEP measured using end-inspiratory and end-expiratory occlusion maneuvers, respectively.
Detailed Description
In 2015, Pediatric Acute Lung Injury Consensus Conference (PALICC) determined the pediatric acute respiratory distress syndrome (PARDS) definition. PALICC recommends using patient-specific tidal volume (VT) according to disease severity. Moreover, in the absence of transpulmonary pressure measurements (PL), an inspiratory plateau pressure limit of 28 cm H2O is recommended, allowing for slightly higher plateau pressures (29-32 cm H2O) for patients with reduced chest wall compliance. In adult ARDS, Amato et al. normalized VT to the compliance(C) by using driving pressure (ΔP) and reported that ΔP was the ventilation variable that best-stratified risk. Changes in ventilator settings resulting in a decrease in ΔP were associated with increased survival. One of the most common modes used in pediatric ventilation nowadays is synchronized controlled mandatory ventilation with adaptive pressure ventilation (APV-CMV). As compared to pressure control mode (P-CMV), APV-CMV prevents low or high VT when the compliance changes by adjusting the applied pressure. Adaptive support ventilation (ASV) is closed-loop ventilation mode, which for a given minute volume set by the clinician, adapts tidal volume (VT) and respiratory rate (RR) according to the patient's respiratory mechanics.
This prospective randomized cross over study aimed to compare ΔP between physician tailored APV-CMV mode and ASV 1.1 in pediatric mechanically ventilated patients with acute respiratory failure. After the enrollment, the patients' ventilation periods will be determined by randomization using sealed opaque envelopes. The minute ventilation, fraction of inspired O2 (FiO2) and positive end-expiratory pressure (PEEP) set by the clinician before study inclusion will be kept unchanged during all study periods. Patients will be ventilated in each mode for 60 minutes. Three consecutive -inspiratory and end-expiratory occlusion will be performed at 30 and 60 min and ΔP will be calculated for each period. Arterial blood gas will be measured at the end of each period. A wash-out period of 30 min using the ventilation mode and setting before inclusion will be performed in between the two study ventilation periods. ΔP will be calculated as the difference between plateau pressure (Pplat) and total PEEP and will be averaged for each ventilation period by using the mean of the six measurements mentioned above. VT will be calculated by integration of flow measurement. Resistance will be calculated by the least-squares fitting method. The expiratory time constant (RCexp) will be derived from the volume-flow curve at 75% of the VT and corresponding flow value. Static compliance (Cstat) will be calculated as VT divided by ΔP.
The primary outcome will be ΔP. The secondary outcome will be VT, RR, Pplat, Ti, Te, Cstat, Resistance, RCexp, pH, PaO2, PaCO2 A pilot study was performed to calculate the sample size. The mean ΔP was 12.4 (±3.31) cm H2O in ASV 1.1 and 13.5 (±4.2) cm H2O in APV-CMV. By using these pilot data, and assuming the power of 0.95 and α-error of 0.05, investigators have calculated the study size as 26 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Driving pressure,, Pediatric acute respiratory distress syndrome (PARDS),, Acute lung injury (ALI),, Closed loop ventilation, Pediatric intnsive care unit (PICU)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional
Arm Type
Active Comparator
Arm Title
Closed-loop
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
closed loop
Intervention Description
RR and VT will be selected according to the respiratory mechanics by closed loop algorithm
Intervention Type
Device
Intervention Name(s)
conventional
Intervention Description
RR, VT, Ti will be selected by the clinician according to the respiratory mechanics
Primary Outcome Measure Information:
Title
Driving pressure
Description
measured with an occlusion maneuver as the difference between plateau pressure (Pplat) and total PEEP
Time Frame
at the end of period (60th minute)
Secondary Outcome Measure Information:
Title
Tidal Volume (VT)
Description
Integrated from flow measurement
Time Frame
continuous measurement over 1 hour
Title
Respiratory rate (RR)
Description
Number of mechanically triggered breaths by the ventilator in 60 seconds
Time Frame
continuous measurement over 1 hour
Title
Expiratory time constant (RCexp)
Time Frame
continious measurement over 1 hour
Title
Static compliance (Cstat)
Description
will be derived from volume-flow curve at 75% of the VT and corresponding flow value
Time Frame
continuous measurement over 1 hour
Title
Inspiratory time (Ti)
Description
Time used for inspiration during each mechanically triggered breath
Time Frame
continuous measurement over 1 hour
Title
Expiratory time (Te)
Description
Time used for expiration during each mechanically triggered breath
Time Frame
continuous measurement over 1 hour
Title
pH
Description
the measure of the hydrogen ion (H-) concentration in arterial blood
Time Frame
one measurement after 1 hour
Title
PaO2
Description
measurement of oxygen pressure in arterial blood
Time Frame
one measurement after 1 hour
Title
PaCO2
Description
measurement of CO2 pressure in arterial blood
Time Frame
one measurement after 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the mechanically ventilated children
between 1-months and 18-years-old
without any detectable respiratory effort
whose clinical condition are not foreseen to change within the next 3 hours
Exclusion Criteria:
septic shock
brain death diagnose,
with a leak equal or more than 40% of the current VT,
receiving extracorporeal membrane oxygenation (ECMO) or targeted temperature management (TTM),
Facility Information:
Facility Name
The Health Sciences University Izmir Behçet Uz Child Health and Diseases education and research hospital
City
İzmir
State/Province
Turkey/izmir
ZIP/Postal Code
35200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
this will be decided depending on the approval of the patients in the written informed consent
Citations:
PubMed Identifier
20228688
Citation
Santschi M, Jouvet P, Leclerc F, Gauvin F, Newth CJ, Carroll CL, Flori H, Tasker RC, Rimensberger PC, Randolph AG; PALIVE Investigators; Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI); European Society of Pediatric and Neonatal Intensive Care (ESPNIC). Acute lung injury in children: therapeutic practice and feasibility of international clinical trials. Pediatr Crit Care Med. 2010 Nov;11(6):681-9. doi: 10.1097/PCC.0b013e3181d904c0.
Results Reference
background
PubMed Identifier
25647235
Citation
Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
Results Reference
background
PubMed Identifier
28936698
Citation
Kneyber MCJ, de Luca D, Calderini E, Jarreau PH, Javouhey E, Lopez-Herce J, Hammer J, Macrae D, Markhorst DG, Medina A, Pons-Odena M, Racca F, Wolf G, Biban P, Brierley J, Rimensberger PC; section Respiratory Failure of the European Society for Paediatric and Neonatal Intensive Care. Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC). Intensive Care Med. 2017 Dec;43(12):1764-1780. doi: 10.1007/s00134-017-4920-z. Epub 2017 Sep 22.
Results Reference
background
PubMed Identifier
25693014
Citation
Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
Results Reference
background
PubMed Identifier
30640889
Citation
Imber DA, Thomas NJ, Yehya N. Association Between Tidal Volumes Adjusted for Ideal Body Weight and Outcomes in Pediatric Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2019 Mar;20(3):e145-e153. doi: 10.1097/PCC.0000000000001846.
Results Reference
background
PubMed Identifier
34293255
Citation
Ceylan G, Topal S, Atakul G, Colak M, Soydan E, Sandal O, Sari F, Agin H. Randomized crossover trial to compare driving pressures in a closed-loop and a conventional mechanical ventilation mode in pediatric patients. Pediatr Pulmonol. 2021 Sep;56(9):3035-3043. doi: 10.1002/ppul.25561. Epub 2021 Jul 22.
Results Reference
derived
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Driving Pressures in a Closed-loop and a Conventional Mechanical Ventilation Mode
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