Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients (CHARM-Bloc)

Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients: A Physiological Study

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Hemodynamic Monitoring; Mechanical Ventilation; Major Abdominal Surgery; Cardiac Output; Stroke Volume; Hemodynamic Optimization; Decreased Cardiac Output
• Intervention / Treatment: Procedure: alveolar recruitment maneuver

Detailed Description

In practice, after induction of general anesthesia and intubation, patients will be conditioned with the recommended monitoring (arterial catheter, central venous catheter, and transpulmonary thermodilution).

Once conditioning is complete, optimization of blood volume will be performed with volumetric expansions (250 mL of Ringer lactate) to achieve a change in stroke volume of less than 10%, as recommended (RFE SFAR 2013 - Perioperative Vascular Filling Strategy). The patient will then be randomized to one of the following groups: [ extended sigh then CPAP ] or [ CPAP then extended sigh ] (random order of ARMs - each patient becoming their own control). In order to homogenize the settings, the mechanical ventilation will be standardized with in particular the use of a PEEP of 6 cmH2O before inclusion and between the ARMs (for a duration of at least 10 minutes in each case).

Hemodynamic values will be recorded during the last 10 seconds of each procedure. Once the two ARMs have been performed, the rest of the management will then be left to the discretion of the practitioner in charge of the patient.

The included patient will be managed according to the recommendations at the time of the study.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous positive airway pressure (CPAP) then extended sigh; 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; 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.
Active Comparator: extended sigh then continuous positive airway pressure (CPAP); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard hemodynamic monitoring data	blood pressure, mean arterial pressure,	last 10 seconds of each ARM modality
Standard hemodynamic monitoring data	heart rate	last 10 seconds of each ARM modality
Invasive hemodynamic monitoring data	stroke volume change in stroke volume	last 10 seconds of each ARM modality
Invasive hemodynamic monitoring data	change in stroke volume	last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data	tidal volume (ml)	last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data	positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure	last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data	respiratory rate,	last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data	inspired oxygen fraction,	last 10 seconds of each ARM modality
Evaluation of standard ventilatory monitoring data	compliance of the respiratory system	last 10 seconds of each ARM modality
Electro-impedancemetry data	Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt : COV : Center Of Ventilation and GI : Global Inhomogeneity index	last 10 seconds of each ARM modality
Electro-impedancemetry data	Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt : TIV : Tidal Impedance Variation	last 10 seconds of each ARM modality
Electro-impedancemetry data	Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt : RVD : Regional Ventilation Delay	last 10 seconds of each ARM modality
Electro-impedancemetry data	Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt : EELI : End Expiratory Lung Impedance	last 10 seconds of each ARM modality
Electro-impedancemetry data	Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt : percentages of overdistended and atelectasis areas	last 10 seconds of each ARM modality
Paraclinics data	During the last 10 seconds of the recruitment maneuver, capnography will be recorded	last 10 seconds of each ARM modality
Paraclinics data	During the last 10 seconds of the recruitment maneuver, SpO2 will be recorded	last 10 seconds of each ARM modality

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: cardiac output; mechanical ventilation,; hemodynamics,; ARM,; CPAP,; extended sigh,
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low
• Other Study ID Numbers: RBHP 2021 GODET 4 (Charm Bloc)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No