Effect Alveolar Recruitment Manoeuver on Stroke Volume a Randomized Study

Not Applicable

• Conditions: Alveolar Recruitment Manoeuver; Anesthesia
• Interventions: Procedure: alveolar recruitment manoeuver

• Registration Number: NCT04802421
• Lead Sponsor: University Hospital, Caen

Brief Summary

Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.

Detailed Description

Following anesthesia and preload optimisation guided by cardiac stroke volume, patients will be randomised to one alveolr recruitment manoeuver :

* stepwise increase and decrease in positive airway pressure

* sustained 30 secondes 30 cmH2O continuous positive airway pressure The primary objective is the change in cardiac stroke volume.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-12
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-10-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• adult patients scheduled for major surgery requiring hemodynamic monitoring
• written signed informed consent

Exclusion Criteria

• pregnancy
• non sinusal heart rate
• known cardiac right ventricular failure or arterial pulmonary hypertension
• pneumothorax
• known pulmonary emphysema

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP30	alveolar recruitment manoeuver	a 30 secondes 30 cmH2O continuous positive airway pressure applied after the orotracheal intubation will be checked and secured following induction of general anesthesia
STEP30	alveolar recruitment manoeuver	a stepwise increase (+5 cmH2O) in postivie airway pressure from +5 cmH2O to +30 cmH2O and decrease (-5 cmH2O) from +30 cmH2O to +5 cmH2O applied after the orotracheal intubation will be checked and secured following induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
cardiac stroke volume	1 min	change in cardiac stroke volume during the alveolar recruitment manoeuver

Secondary Outcome Measures

Name	Time	Method
arterial pressure	1 min	change in arterial pressure during the alveolar recruitment manoeuver
recovery at 3 min	3 min	recovery of cardiacstroke volume and arterial pressure 3 min after the end of alveolar recruitment manoeuver

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, France