Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000554268
Ethics application status
Approved
Date submitted
2/12/2017
Date registered
13/04/2018
Date last updated
10/12/2019
Date data sharing statement initially provided
12/04/2019
Date results information initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome after cardiac thoracic surgery
Scientific title
Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome after cardiac thoracic surgery
Secondary ID [1] 293393 0
none
Universal Trial Number (UTN)
none
Trial acronym
The DROP study: DRiving pressure for Optimization of Positive end-expiratory pressure
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory distress syndrome 305536 0
Positive end-expiratory pressure 305537 0
post operative cardiothoracic surgery 305538 0
Condition category
Condition code
Respiratory 304770 304770 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Descriptive study where data are reported from patients with acute respiratory distress syndrome who receive daily mechanical ventilation with volume-controlled mode. A decremental PEEP procceding was done: maximun PEEP for a plateau pressure <30 cm H2O, then PEEP was set to 15, 10, and 5 cm H2O. A blood gas analysis was performed between each PEEP level after a period of 15 minutes. PEEP was set according to the best oxygenation result (PaO2/FiO2 ratio). Duration of observation was expected to be 1 hour."
The patients are already receiving decremental PEEP as part of standard care and we then collected data from then. Finally, no change are made to patientcare.
Intervention code [1] 299655 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304008 0
Best PEEP level based on the best driving pressure value. The different PEEP levels generated different driving pressure values. The lower driving pressure value recorded was retained as the best driving pressure value. This lower driving pressure recorded defined the best PEEP value. Drving pressure is defined as: plateau pressure-total PEEP. Plateau pressure (cm H2O) was measured during an inspiratory pause on the ventilator Total PEEP (cm H2O) was measured during an expiratory pause on the ventilator.
Timepoint [1] 304008 0
For every patient after completion of the PEEP proceeding at day 1 of enrollement
Primary outcome [2] 304110 0
Best PEEP level based on the best oxygenation value defined by the PaO2/FiO2 ratio. The different PEEP levels generated different PaO2/FiO2 values. The higher PaO2/FiO2 value recorded was retained as the best oxygenation value. This higher PaO2/FiO2 ratio recorded defined the best PEEP value. PaO2 was obtained by blood gas analysis and FiO2 is the value displayed by the ventilator.
Timepoint [2] 304110 0
For every patient after completion of the PEEP proceeding at day 1 of enrollement
Secondary outcome [1] 340707 0
Mean arterial pressure.was recorded at each PEEP levels. A decrease of mean arterial pressure > 20% was considered significant. Mean arterial pressure was obtained by an arterial catheter which recorded arterial pressure continuously and displayed the values on a monitor screen.
. .
Timepoint [1] 340707 0
For every patient after completion of the PEEP trial at day 1 of enrollement
Secondary outcome [2] 343499 0
Heart rate: Occurrence of bradycardia (heart rate<60/min) or tachycardia (Heart rate > 140/min) was considered significant at each PEEP level. Heart rate is continously recorded and the values are displayed on a monitor screen
Timepoint [2] 343499 0
For every patient after completion of the PEEP proceeding at day 1 of enrollement
Secondary outcome [3] 343500 0
Atrial fibrillation was considered on EKG continuously displayed by a monitor and confirmed by an EKG tracing on a paper at each PEEP level.
Timepoint [3] 343500 0
For every patient after completion of the PEEP proceeding at day 1 of enrollement
Secondary outcome [4] 343501 0
Flutter was considered on EKG continuously displayed by a monitor and confirmed by an EKG tracing on a paper at each PEEP level
Timepoint [4] 343501 0
For every patient after completion of the PEEP proceeding at day 1 of enrollement
Secondary outcome [5] 343502 0
Atrio ventricular block was considered on EKG continuously displayed by a monitor and confirmed by an EKG tracing on a paper at each PEEP level
Timepoint [5] 343502 0
For every patient after completion of the PEEP proceeding at day 1 of enrollement

Eligibility
Key inclusion criteria
all ICU patients with Acute respiratory distress syndrome (ARDS)
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undrained pneumothoraces
Hemodynamic instability defined by increased need of vasopressors and / or an systolic arterial pressure below 90 mmHg
Hypovolemic shock
Bronchopleural fistula
High intracranial pressure

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To test wether the means of PEEP based of the best driving pressure or the best PaO2/FiO2 ratio are equivalent, 118 patients should be included with an hypothesis of a mean of the best PEEP of 10 cm H2Owith a standard deviation of 3.5 cm H2O. We set the non inferiority or superiority margin at 1.5 cmH2O.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2018
Actual
6/11/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
27/05/2019
Date of last data collection
Anticipated
15/07/2019
Actual
14/06/2019
Sample size
Target
118
Accrual to date
Final
123
Recruitment outside Australia
Country [1] 9367 0
France
State/province [1] 9367 0
ile de france

Funding & Sponsors
Funding source category [1] 298019 0
Hospital
Name [1] 298019 0
Hopital Marie Lannelongue
Country [1] 298019 0
France
Primary sponsor type
Hospital
Name
Hopital Marie Lannelongue
Address
133 av de la Resistance
92350 Le Plessis Robinson
Country
France
Secondary sponsor category [1] 297092 0
None
Name [1] 297092 0
Address [1] 297092 0
Country [1] 297092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299054 0
Comité d'Ethique de l'Hôpital Marie Lannelongue 16/12/2016
Ethics committee address [1] 299054 0
133 av de la Resistance
92350 Le Plessis Robinson
Ethics committee country [1] 299054 0
France
Date submitted for ethics approval [1] 299054 0
02/12/2016
Approval date [1] 299054 0
16/12/2016
Ethics approval number [1] 299054 0
2016-21

Summary
Brief summary
Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or driving pressure in patients with acute respiratory distress syndrome (ARDS) after cardiothoracic surgery

The use of a positive end-expiratory pressure in acute respiratory distress syndrome is obvious in ARDS management. On the one hand it serves to fight against the reduction of functional residual capacity (FRC) and enable the limitation of hypoxia; and on the other hand it allows the limitation of “opening/closing” lesions in pulmonary alveoli which lead to increase “bio trauma”.
However elevated PEEP has harmful effect such as hemodynamic effect on the right ventricle and distension on healthy part of the lung.Other adverse effects are: decreasing cardiac output, increased risk of barotrauma, and the interference with assessment of hemodynamic pressures.
Ideally the adjustment of PEEP level must be done by taking into account each patient characteristic. PEEP titration based on blood gas analysis is one of the most used techniques by physicians.
Current guidelines for lung-protective ventilation in patients with acute respiratory distress syndrome (ARDS) suggest the use of low tidal volumes (Vt), set according to ideal body weight (IBW) of the patient, and higher levels of positive end-expiratory pressure (PEEP) to limit ventilator-induced lung injury (VILI). However, recent studies have shown that ARDS patients who are ventilated according to these guidelines may still be exposed to forces that can induce or aggravate lung injury.
Driving pressure (DP) is the difference between the airway pressure at the end of inspiration (plateau pressure, Ppl) and PEEP.
Driving pressure may be a valuable tool to set PEEP. Independent of the strategy used to titrate PEEP, changes in PEEP levels should consider the impact on driving pressure, besides other variables such as gas exchange and hemodynamics. A decrease in driving pressure after increasing PEEP will necessarily reflect recruitment and a decrease in cyclic strain. On the contrary, an increase in driving pressure will suggest a non-recruitable lung, in which overdistension prevails over recruitment.
The main purposes of this study are to assess the optimal PEEP based on the best driving pressure or the best oxygenation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79126 0
Prof STEPHAN Francois
Address 79126 0
Hôpital Marie Lannelongue
133 av de la Resistance
92350 Le Plessis Robinson
Country 79126 0
France
Phone 79126 0
+33 1 40948580
Fax 79126 0
+33 140948586
Email 79126 0
[email protected]
Contact person for public queries
Name 79127 0
Mr TUYINDI MVUALA Rudy
Address 79127 0
Hôpital Marie Lannelongue
133 av de la Resistance
92350 Le Plessis Robinson
Country 79127 0
France
Phone 79127 0
+33 1 40942554
Fax 79127 0
+33 140948586
Email 79127 0
[email protected]
Contact person for scientific queries
Name 79128 0
Mr TUYINDI MVUALA Rudy
Address 79128 0
Hôpital Marie Lannelongue
133 av de la Resistance
92350 Le Plessis Robinson
Country 79128 0
France
Phone 79128 0
+33 140942554
Fax 79128 0
+33 140948586
Email 79128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Hemodynamic data and respiratory variables
When will data be available (start and end dates)?
start date of IPD availability: 1 june 2020
End date of IPD availability: 30 november 2020
Available to whom?
Physician working in my hospital.
Experts in the field of mechanical ventilation in ARDS
Available for what types of analyses?
Developing new cocepts in the field of ventilatory management in ARDS
How or where can data be obtained?
Excel sheet


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1758Ethical approval    374017-(Uploaded-30-03-2019-04-07-05)-Study-related document.pdf
1759Ethical approval    374017-(Uploaded-30-03-2019-04-07-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOxygenation versus driving pressure for determining the best positive end-expiratory pressure in acute respiratory distress syndrome.2022https://dx.doi.org/10.1186/s13054-022-04084-z
N.B. These documents automatically identified may not have been verified by the study sponsor.