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Completed

NCT Number: NCT05365113

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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)

    Time frame: last 10 seconds of each ARM modality

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

Secondary outcomes

  1. Standard hemodynamic monitoring data

    Time frame: last 10 seconds of each ARM modality

    blood pressure, mean arterial pressure,

  2. Standard hemodynamic monitoring data

    Time frame: last 10 seconds of each ARM modality

    heart rate

  3. Invasive hemodynamic monitoring data

    Time frame: last 10 seconds of each ARM modality

    stroke volume change in stroke volume

  4. Invasive hemodynamic monitoring data

    Time frame: last 10 seconds of each ARM modality

    change in stroke volume

  5. Evaluation of standard ventilatory monitoring data

    Time frame: last 10 seconds of each ARM modality

    tidal volume (ml)

  6. Evaluation of standard ventilatory monitoring data

    Time frame: last 10 seconds of each ARM modality

    positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure

  7. Evaluation of standard ventilatory monitoring data

    Time frame: last 10 seconds of each ARM modality

    respiratory rate,

  8. Evaluation of standard ventilatory monitoring data

    Time frame: last 10 seconds of each ARM modality

    inspired oxygen fraction,

  9. Evaluation of standard ventilatory monitoring data

    Time frame: last 10 seconds of each ARM modality

    compliance of the respiratory system

  10. Electro-impedancemetry data

    Time frame: last 10 seconds of each ARM modality

    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

  11. Electro-impedancemetry data

    Time frame: last 10 seconds of each ARM modality

    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

  12. Electro-impedancemetry data

    Time frame: last 10 seconds of each ARM modality

    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

  13. Electro-impedancemetry data

    Time frame: last 10 seconds of each ARM modality

    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

  14. Electro-impedancemetry data

    Time frame: last 10 seconds of each ARM modality

    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

  15. Paraclinics data

    Time frame: last 10 seconds of each ARM modality

    During the last 10 seconds of the recruitment maneuver, capnography will be recorded

  16. Paraclinics data

    Time frame: last 10 seconds of each ARM modality

    During the last 10 seconds of the recruitment maneuver, SpO2 will be recorded

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: CHARM-Bloc

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 9, 2022
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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