Effect Alveolar Recruitment Manoeuver on Stroke Volume a Randomized Study

NCT04802421 | Unknown

• 1 other identifier: CHU Caen Normandie 19-024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Recruitment Manoeuver; Anesthesia

Outcome Measures

Primary Outcomes (1)

• cardiac stroke volume

  change in cardiac stroke volume during the alveolar recruitment manoeuver

  1 min

Secondary Outcomes (2)

• arterial pressure

  1 min

• recovery at 3 min

  3 min

Study Arms (2)

CPAP30

ACTIVE COMPARATOR

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

STEP30

ACTIVE COMPARATOR

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

Interventions

alveolar recruitment manoeuver PROCEDURE

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

CPAP30; STEP30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, 14000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 38017197 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised parallel groups. randomisation between 2 groups equilibated by randomised blocks of 4, 6 or 8

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: March 12, 2021
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)