Effect Alveolar Recruitment Manoeuver on Stroke Volume a Randomized Study

NCT ID: NCT04802421

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2022-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alveolar Recruitment Manoeuver Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised parallel groups. randomisation between 2 groups equilibated by randomised blocks of 4, 6 or 8
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers
The patient will not know the allocation group because he will be anesthetised before randomisation. The care provider (anesthetist) will not know the allocation group because the intervention will be applied by an independent investigator not involved in care of the patient.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

alveolar recruitment manoeuver

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

alveolar recruitment manoeuver

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

alveolar recruitment manoeuver

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Caen

Caen, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jean-Luc Hanouz, M.D.,Ph.D.

Role: primary

+33 2 31 06 47 36

Cathy Gaillard

Role: backup

+33 2 31 06 53 49

References

Explore related publications, articles, or registry entries linked to this study.

Dupont K, Lefrancois V, Delahaye A, Sanz M, Hestin R, Doublet T, Parienti JJ, Hanouz JL. Change in stroke volume during alveolar recruitment maneuvers through transient continuous positive airway pressure or stepwise increase in positive end expiratory pressure in anesthetized patients: a prospective randomized double-blind study. Can J Anaesth. 2024 Feb;71(2):224-233. doi: 10.1007/s12630-023-02644-7. Epub 2023 Nov 28.

Reference Type DERIVED
PMID: 38017197 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHU Caen Normandie 19-024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.