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Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers - ICU Patients (CHARM-ICU)

Primary Purpose

Cardiac Output, Hemodynamic Optimization, Monitoring Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Alveolar Recruitment Maneuver (ARM)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for 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
  • 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)

Sites / Locations

  • CHURecruiting

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 ARM 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

The secondary outcome measures are the evaluation of standard hemodynamic monitoring data
During the last 10 seconds of the recruitment maneuver, standard hemodynamic monitoring data will be recorded : blood pressure (mmHg) mean arterial pressure (mmHg)
Standard hemodynamic monitoring data
heart rate
Invasive hemodynamic monitoring data
stroke volume (ml/min)
Invasive hemodynamic monitoring data
change in stroke volume
Standard ventilatory monitoring data
tidal volume (ml)
Standard ventilatory monitoring data
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure,
Standard ventilatory monitoring data
respiratory rate
Standard ventilatory monitoring data
inspired oxygen fraction
Standard ventilatory monitoring data
compliance of the respiratory system
Electrical impedance tomography data
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 : Tidal Impedance Variation (TIV)
Electrical impedance tomography data
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 : Center Of Ventilation (COV) and Global Inhomogeneity index (GI)
Electrical impedance tomography data
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 : Regional Ventilation Delay (RVD)
Electrical impedance tomography data
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 : End Expiratory Lung Impedance (EELI)
Electrical impedance tomography data
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 : percentages of overdistended and atelectasis areas
The secondary outcome measures are the evaluation of paraclinical data
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
The secondary outcome measures are the evaluation of paraclinical data
During the last 10 seconds of the recruitment maneuver, pulse oxygen saturation (SpO2) will be recorded

Full Information

First Posted
April 19, 2022
Last Updated
May 8, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05365854
Brief Title
Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers - ICU Patients
Acronym
CHARM-ICU
Official Title
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Intensive Care Unit Patients Under Mechanical Ventilation. A Pilot Physiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Hemodynamic Optimization, Monitoring Blood Pressure, Stroke Volume, Mechanical Ventilation, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

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 (ARM)
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 ARM 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
During procedure (last 10 seconds of each ARM modality)
Secondary Outcome Measure Information:
Title
The secondary outcome measures are the evaluation of standard hemodynamic monitoring data
Description
During the last 10 seconds of the recruitment maneuver, standard hemodynamic monitoring data will be recorded : blood pressure (mmHg) mean arterial pressure (mmHg)
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Standard hemodynamic monitoring data
Description
heart rate
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Invasive hemodynamic monitoring data
Description
stroke volume (ml/min)
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Invasive hemodynamic monitoring data
Description
change in stroke volume
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Standard ventilatory monitoring data
Description
tidal volume (ml)
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Standard ventilatory monitoring data
Description
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure,
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Standard ventilatory monitoring data
Description
respiratory rate
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Standard ventilatory monitoring data
Description
inspired oxygen fraction
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Standard ventilatory monitoring data
Description
compliance of the respiratory system
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Electrical impedance tomography data
Description
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 : Tidal Impedance Variation (TIV)
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Electrical impedance tomography data
Description
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 : Center Of Ventilation (COV) and Global Inhomogeneity index (GI)
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Electrical impedance tomography data
Description
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 : Regional Ventilation Delay (RVD)
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Electrical impedance tomography data
Description
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 : End Expiratory Lung Impedance (EELI)
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
Electrical impedance tomography data
Description
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 : percentages of overdistended and atelectasis areas
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
The secondary outcome measures are the evaluation of paraclinical data
Description
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
Time Frame
During procedure (last 10 seconds of each ARM modality)
Title
The secondary outcome measures are the evaluation of paraclinical data
Description
During the last 10 seconds of the recruitment maneuver, pulse oxygen saturation (SpO2) will be recorded
Time Frame
During procedure (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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
+33 473754963
Email
llaclautre_perrier@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Godet
Email
tgodet@chu-clermontferrand.fr

12. IPD Sharing Statement

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

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