Effect Alveolar Recruitment Manoeuver on Stroke Volume a Randomized Study (hemorecrut-2)

March 15, 2021 updated by: University Hospital, Caen

Hemodynamic Effect of Alveolar Recruitment Manoeuver Through Stepwise Increase and Decrease in Irway Pressure or Sustained 30 Secondes 30 cmH2O Continuous Positive Airway Pressure. A Randomized Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPAP30
a 30 secondes 30 cmH2O continuous positive airway pressure applied after the orotracheal intubation will be checked and secured following induction of general anesthesia
Procedure: alveolar recruitment manoeuver
alveolar recruitment manoeuver are recommended during general anesthesia to prevent pulmonary atelectasis
Active Comparator: STEP30
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
Procedure: alveolar recruitment manoeuver
alveolar recruitment manoeuver are recommended during general anesthesia to prevent pulmonary atelectasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac stroke volume
Time Frame: 1 min
change in cardiac stroke volume during the alveolar recruitment manoeuver
1 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial pressure
Time Frame: 1 min
change in arterial pressure during the alveolar recruitment manoeuver
1 min
recovery at 3 min
Time Frame: 3 min
recovery of cardiacstroke volume and arterial pressure 3 min after the end of alveolar recruitment manoeuver
3 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CHU Caen Normandie 19-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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