Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients

NCT05365113 | Completed

• 1 other identifier: RBHP 2021 GODET 4 (Charm Bloc)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the hemodynamic effects of two strategies of alveolar recruitment maneuver in patients undergoing major abdominal surgery in the operating room

Conditions

Cardiac Output; Decreased Cardiac Output; Hemodynamic Monitoring; Blood Pressure; Stroke Volume; Major Abdominal Surgery; Mechanical Ventilation; Hemodynamic Optimization

Keywords

mechanical ventilation,; hemodynamics,; ARM,; CPAP,; extended sigh,; cardiac output

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the change in cardiac output during the last 10 seconds of each MRA modality from its baseline value (determined after hemodynamic optimization and before the procedure was performed)

  Cardiac output (l/min) will be measured by invasive monitoring during the last 10 seconds of each recruitment maneuver

  last 10 seconds of each ARM modality

Secondary Outcomes (16)

• Standard hemodynamic monitoring data

  last 10 seconds of each ARM modality

• Standard hemodynamic monitoring data

  last 10 seconds of each ARM modality

• Invasive hemodynamic monitoring data

  last 10 seconds of each ARM modality

• Invasive hemodynamic monitoring data

  last 10 seconds of each ARM modality

• Evaluation of standard ventilatory monitoring data

  last 10 seconds of each ARM modality

Study Arms (2)

Continuous positive airway pressure (CPAP) then extended sigh

ACTIVE COMPARATOR

Patients assigned to this group will receive a CPAP ARM (40cmH2O during 50 seconds), followed by a 10-minute pause corresponding to a period of return to basal state. Then an ARM by extended sigh (e-sigh) also 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure). Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver.

Procedure: alveolar recruitment maneuver

extended sigh then continuous positive airway pressure (CPAP)

ACTIVE COMPARATOR

Patients assigned to this group will receive an ARM by extended sigh (e-sigh) during 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure), followed by a 10-minute pause corresponding to a period of return to basal state. Then they receive a CPAP ARM (40cmH2O during 50 seconds). Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver.

Procedure: alveolar recruitment maneuver

Interventions

alveolar recruitment maneuver PROCEDURE

When patient is under general anesthesia, an arterial catheter is placed for cardiac output and stroke volume (SV) monitoring. To avoid pre-load dependency bias, the blood volume will be optimized. A 250mL fluid-challenge of a balanced crystalloid solution is administered under cover of the SV monitoring. If SV variation is greater than 10%, a new fluid-challenge is performed to obtain a reference SV, corresponding to the patient's optimal blood volume.The patient is then "pre-load independent". Then, patients will be randomized into two groups: a first group will receive a CPAP ARM: 40 cmH2O for 50 seconds, followed by a 10-minute break corresponding to a period of return to basal state; then an extended sigh ARM (e-sigh) also lasting 50seconds (driving pressure: 10cmH2O and successive PEEP levels at 10,15,20,25 and 30cmH2O, a respiratory rate set at 30/min in controlled pressure - 5cycles at each PEEP level); a second group will receive the same two ARM modalities in reverse order.

Continuous positive airway pressure (CPAP) then extended sigh; extended sigh then continuous positive airway pressure (CPAP)

Eligibility Criteria

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

You may qualify if:

• patient over 18 years old
• patient under general anesthesia
• patient intubated under controlled invasive mechanical ventilation
• patient with invasive hemodynamic monitoring (transpulmonary thermodilution)
• patient sedated (BIS between 40 and 60) and/or curarized with TOF monitoring to avoid inspiratory effort
• patient optimized on the hemodynamic level, in particular with regard to blood volume, following the hemodynamic monitoring data and the recommendations of the French Society of Anesthesia and Resuscitation (RFE SFAR 2013 - Perioperative vascular filling strategy)
• patient covered by a Social Security plan
• patient consent to participate in the study

You may not qualify if:

• contraindication to the use of cardiac output measurement
• cardiac arrhythmia
• pace-maker/implantable defibrillator
• severe valvulopathy
• contraindication to the use of the tomographic electroimpedancemetry technique
• thoracic lesions, thoracic dressing
• left ventricular ejection fraction (LVEF) \< 45% and/or right ventricular failure.
• history of pulmonary lobectomy and/or pneumonectomy and/or known emphysema
• patient with restrictive or obstructive lung disease
• body mass index (BMI) \< 16.5 or \> 30 kg.m-2
• pregnancy
• intracranial hypertension or suspected intracranial hypertension
• patient under limitation of care
• patient under legal protection (guardianship, curatorship, safeguard of justice)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory study testing in cross-sectional design two alveolar recruitment maneuvers referenced in practice, in patients under general anesthesia and intubated under controlled ventilation, in operating room

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 9, 2022
• Study Start: March 9, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

FR (1)