Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit

Completed

• Conditions: Positive-Pressure Respiration
• Interventions: Device: echocardiography; Device: Arterial oximetry

• Registration Number: NCT02805036
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.

In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.

The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:

* An end-tidal plateau at 30 cmH20 for 30 seconds.

* An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-17
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All sedated, intubated, mechanically ventilated adult patients (over-18) admitted to the surgical intensive care unit and equipped with a central venous catheter and an arterial catheter.
• Good echogenicity
• Social security coverage

Exclusion Criteria

• Pregnancy
• Cardiac arrhythmia
• Poor echogenicity
• Legal guardianship or incarceration
• Systolic blood pressure ≤90 mmHg
• Respiratory distress
• Patients admitted on an emergency basis (first 24 hours), i.e. not for elective surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
30 cmH20 for 30 seconds	Arterial oximetry	plateau pressure is hold on at 30 cmH20 pour 30 seconds. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later. echocardiography - arterial oximetry
10 cmH20 above	echocardiography	plateau pressure is hold on at 10 cmH20 above. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later. echocardiography - arterial oximetry
10 cmH20 above	Arterial oximetry	plateau pressure is hold on at 10 cmH20 above. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later. echocardiography - arterial oximetry
30 cmH20 for 30 seconds	echocardiography	plateau pressure is hold on at 30 cmH20 pour 30 seconds. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later. echocardiography - arterial oximetry

Primary Outcome Measures

Name	Time	Method
Variations in cardiac output induced by each type of AR manoeuvre	Day 0

Secondary Outcome Measures

Name	Time	Method
Variations in PaO2 variations induced by each type of AR manoeuvre	Day 0

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France