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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04802421
Other study ID # CHU Caen Normandie 19-024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 12, 2021
Est. completion date April 1, 2022

Study information

Verified date March 2021
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date April 1, 2022
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
alveolar recruitment manoeuver
alveolar recruitment manoeuver are recommended during general anesthesia to prevent pulmonary atelectasis

Locations

Country Name City State
France CHU de Caen Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary cardiac stroke volume change in cardiac stroke volume during the alveolar recruitment manoeuver 1 min
Secondary arterial pressure change in arterial pressure during the alveolar recruitment manoeuver 1 min
Secondary recovery at 3 min recovery of cardiacstroke volume and arterial pressure 3 min after the end of alveolar recruitment manoeuver 3 min
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