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

• Register: ANZCTR
• Last refreshed on: 6 January 2020
• Main ID: ACTRN12618000554268
• Date of registration: 13/04/2018
• Prospective Registration: Yes
• Primary sponsor: Hopital Marie Lannelongue
• 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
• Date of first enrolment: 06/11/2018
• Target sample size: 118
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000554268.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

France

Contacts

• Name: Mr TUYINDI MVUALA Rudy

• Name: Mr TUYINDI MVUALA Rudy

Key inclusion & exclusion criteria

Inclusion criteria: all ICU patients with Acute respiratory distress syndrome (ARDS)
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


Age minimum: 15 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Respiratory - Other respiratory disorders / diseases

Acute respiratory distress syndrome;Positive end-expiratory pressure;post operative cardiothoracic surgery;
Acute respiratory distress syndrome
Positive end-expiratory pressure
post operative cardiothoracic surgery

Intervention(s)

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.

Primary Outcome(s)

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

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

Secondary Outcome(s)

Flutter was considered on EKG continuously displayed by a monitor and confirmed by an EKG tracing on a paper at each PEEP level[For every patient after completion of the PEEP proceeding at day 1 of enrollement]

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

Atrial fibrillation was considered on EKG continuously displayed by a monitor and confirmed by an EKG tracing on a paper at each PEEP level.
[For every patient after completion of the PEEP proceeding at day 1 of enrollement]

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

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

Secondary ID(s)

none

Source(s) of Monetary Support

Hopital Marie Lannelongue

Ethics review

Status: Approved
Approval date:
Contact:

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

Results

• Date Posted: 10/12/2019
• Date Completed: 14/06/2019