Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers - ICU Patients

NCT ID: NCT05365854

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-03-01

Brief Summary

The objective of this study was to investigate the hemodynamic effects of two alveolar recruitment maneuver strategies in critical care patients with acute respiratory distress syndrome.

Detailed Description

Critical care patients are at risk of significant variations in blood volume due to long intervention times, major bleeding or serious pathological conditions, requiring invasive hemodynamic monitoring in routine practice, in order to optimize blood volume and ensure adequate perfusion of the organs, throughout their care.

The installation of an arterial catheter allows continuous monitoring of blood pressure and the realization of blood tests if necessary.

The installation of a central venous line allows the administration of anesthetic drugs and vasopressors as well as an accurate hemodynamic evaluation by transpulmonary thermodilution, which is the most commonly used monitoring in these situations.

After hemodynamic optimization following the monitoring data, the patient will be randomized to one of the two Alveolar Recruitment Maneuver (ARM) order strategies. Mechanical ventilation will be standardized according to current international recommendations (tidal volume between 6 mL.kg-1 and 8 mL.kg-1 of theoretical ideal weight (TIP) for patients with Acute Respiratory Distress Syndrome (ARDS); PEEP equal to 6 cmH2O). Hemodynamic and ventilatory data will be collected (baseline).

The successive realization of the two ARM will then be carried out with collection of the hemodynamic and ventilatory data during the last 10 seconds of each ARM. Between each ARM, conventional ventilation will be resumed for 10 minutes in order to observe a wash-out period, and to allow a return to the baseline state. Data will also be collected as before.

After these measurements have been taken, all management will be left to the discretion of the practitioner caring for the patient.

Conditions

Cardiac Output; Hemodynamic Optimization; Monitoring Blood Pressure; Stroke Volume; Mechanical Ventilation; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

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 (ARM)

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 (ARM)

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 (ARM)

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
• Intubated patient under controlled invasive mechanical ventilation
• Patient with invasive hemodynamic monitoring allowing monitoring of cardiac output and stroke volume
• Patient sufficiently sedated (BIS between 40 and 60) and/or curarized (TOF < 2/4 at the orbicularis) to avoid inspiratory effort
• Patient optimized on the hemodynamic level, in particular with regard to blood volume, following the data from hemodynamic monitoring 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
• Consent of close relatives or trusted person (if present)
• Patient admitted in polyvalent resuscitation within the Peri-Operative Medicine Unit of Clermont-Ferrand hospital suffering from respiratory distress syndrome for less than 24 hours

Exclusion Criteria

• Contraindication to the use of cardiac output measurement by transpulmonary thermodilution
• Cardiac arrhythmia
• Severe valvulopathy
• Contraindication to the use of the Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :

technique

• Left ventricular ejection fraction (LVEF) < 45% and/or right ventricular failure
• History of pulmonary lobectomy and/or pneumectomy and/or known emphysema
• Patient with restrictive or obstructive lung disease
• Body mass index (BMI) < 16.5 or > 30 kg.m-2
• Pregnancy
• Major under legal protection (guardianship, curators, 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

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

llaclautre_perrier@chu-clermontferrand.fr

+33 473754963

Facility Contacts

Thomas Godet

Role: primary

tgodet@chu-clermontferrand.fr

Other Identifiers

RBPH 2021 GODET 3 (Charm ICU)

Identifier Type: -

Identifier Source: org_study_id