ANZCTR - Registration

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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

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]

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

Positive end-expiratory pressure

post operative cardiothoracic surgery

Condition category

Condition code

Respiratory

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]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

For every patient after completion of the PEEP proceeding at day 1 of enrollement

Primary outcome [2]

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]

For every patient after completion of the PEEP proceeding at day 1 of enrollement

Secondary outcome [1]

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]

For every patient after completion of the PEEP trial at day 1 of enrollement

Secondary outcome [2]

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]

For every patient after completion of the PEEP proceeding at day 1 of enrollement

Secondary outcome [3]

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]

For every patient after completion of the PEEP proceeding at day 1 of enrollement

Secondary outcome [4]

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]

For every patient after completion of the PEEP proceeding at day 1 of enrollement

Secondary outcome [5]

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]

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?

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]

France

State/province [1]

ile de france

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hopital Marie Lannelongue

Address [1]

133 av de la Resistance
92350 Le Plessis Robinson

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comité d'Ethique de l'Hôpital Marie Lannelongue 16/12/2016

Ethics committee address [1]

133 av de la Resistance
92350 Le Plessis Robinson

Ethics committee country [1]

France

Date submitted for ethics approval [1]

02/12/2016

Approval date [1]

16/12/2016

Ethics approval number [1]

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

Prof STEPHAN Francois

Address

Hôpital Marie Lannelongue
133 av de la Resistance
92350 Le Plessis Robinson

Country

France

Phone

+33 1 40948580

Fax

+33 140948586

f.stephan@ccml.fr

Contact person for public queries

Name

TUYINDI MVUALA Rudy

Address

Hôpital Marie Lannelongue
133 av de la Resistance
92350 Le Plessis Robinson

Country

France

Phone

+33 1 40942554

Fax

+33 140948586

r.tuyindimvuala@ccml.fr

Contact person for scientific queries

Name

TUYINDI MVUALA Rudy

Address

Hôpital Marie Lannelongue
133 av de la Resistance
92350 Le Plessis Robinson

Country

France

Phone

+33 140942554

Fax

+33 140948586

r.tuyindimvuala@ccml.fr

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.	Type	Citation	Link	Email	Other Details	Attachment
1758	Ethical approval					374017-(Uploaded-30-03-2019-04-07-05)-Study-related document.pdf
1759	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Oxygenation versus driving pressure for determining the best positive end-expiratory pressure in acute respiratory distress syndrome.	2022	https://dx.doi.org/10.1186/s13054-022-04084-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically