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

NCT ID: NCT05365113

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2022-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

alveolar recruitment maneuver

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

alveolar recruitment maneuver

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU

Clermont-Ferrand, , France

Countries

France

Other Identifiers

RBHP 2021 GODET 4 (Charm Bloc)

Identifier Type: -

Identifier Source: org_study_id