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

Primary Purpose

Cardiac Output, Decreased Cardiac Output, Hemodynamic Monitoring

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
alveolar recruitment maneuver
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Output focused on measuring mechanical ventilation,, hemodynamics,, ARM,, CPAP,, extended sigh,, cardiac output

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous positive airway pressure (CPAP) then extended sigh

extended sigh then continuous positive airway pressure (CPAP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Standard hemodynamic monitoring data
blood pressure, mean arterial pressure,
Standard hemodynamic monitoring data
heart rate
Invasive hemodynamic monitoring data
stroke volume change in stroke volume
Invasive hemodynamic monitoring data
change in stroke volume
Evaluation of standard ventilatory monitoring data
tidal volume (ml)
Evaluation of standard ventilatory monitoring data
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure
Evaluation of standard ventilatory monitoring data
respiratory rate,
Evaluation of standard ventilatory monitoring data
inspired oxygen fraction,
Evaluation of standard ventilatory monitoring data
compliance of the respiratory system
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
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
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
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
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
Paraclinics data
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
Paraclinics data
During the last 10 seconds of the recruitment maneuver, SpO2 will be recorded

Full Information

First Posted
April 19, 2022
Last Updated
June 15, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05365113
Brief Title
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients
Acronym
CHARM-Bloc
Official Title
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients: A Physiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous positive airway pressure (CPAP) then extended sigh
Arm Type
Active Comparator
Arm Description
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.
Arm Title
extended sigh then continuous positive airway pressure (CPAP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
alveolar recruitment maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
Cardiac output (l/min) will be measured by invasive monitoring during the last 10 seconds of each recruitment maneuver
Time Frame
last 10 seconds of each ARM modality
Secondary Outcome Measure Information:
Title
Standard hemodynamic monitoring data
Description
blood pressure, mean arterial pressure,
Time Frame
last 10 seconds of each ARM modality
Title
Standard hemodynamic monitoring data
Description
heart rate
Time Frame
last 10 seconds of each ARM modality
Title
Invasive hemodynamic monitoring data
Description
stroke volume change in stroke volume
Time Frame
last 10 seconds of each ARM modality
Title
Invasive hemodynamic monitoring data
Description
change in stroke volume
Time Frame
last 10 seconds of each ARM modality
Title
Evaluation of standard ventilatory monitoring data
Description
tidal volume (ml)
Time Frame
last 10 seconds of each ARM modality
Title
Evaluation of standard ventilatory monitoring data
Description
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure
Time Frame
last 10 seconds of each ARM modality
Title
Evaluation of standard ventilatory monitoring data
Description
respiratory rate,
Time Frame
last 10 seconds of each ARM modality
Title
Evaluation of standard ventilatory monitoring data
Description
inspired oxygen fraction,
Time Frame
last 10 seconds of each ARM modality
Title
Evaluation of standard ventilatory monitoring data
Description
compliance of the respiratory system
Time Frame
last 10 seconds of each ARM modality
Title
Electro-impedancemetry data
Description
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
Time Frame
last 10 seconds of each ARM modality
Title
Electro-impedancemetry data
Description
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
Time Frame
last 10 seconds of each ARM modality
Title
Electro-impedancemetry data
Description
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
Time Frame
last 10 seconds of each ARM modality
Title
Electro-impedancemetry data
Description
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
Time Frame
last 10 seconds of each ARM modality
Title
Electro-impedancemetry data
Description
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
Time Frame
last 10 seconds of each ARM modality
Title
Paraclinics data
Description
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
Time Frame
last 10 seconds of each ARM modality
Title
Paraclinics data
Description
During the last 10 seconds of the recruitment maneuver, SpO2 will be recorded
Time Frame
last 10 seconds of each ARM modality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

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

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