An interventional study of Alveolar Recruitment Maneuver (ARM) in Cardiac Output, Hemodynamic Optimization and Monitoring Blood Pressure, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-12.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
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.
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.
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This study's planned enrollment of 20 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
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technique
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.
Procedure: Alveolar Recruitment Maneuver (ARM)
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.
Procedure: 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.
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
Time frame: During procedure (last 10 seconds of each ARM modality)
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)
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard hemodynamic monitoring data
heart rate
Time frame: During procedure (last 10 seconds of each ARM modality)
Invasive hemodynamic monitoring data
stroke volume (ml/min)
Time frame: During procedure (last 10 seconds of each ARM modality)
Invasive hemodynamic monitoring data
change in stroke volume
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
tidal volume (ml)
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure,
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
respiratory rate
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
inspired oxygen fraction
Time frame: During procedure (last 10 seconds of each ARM modality)
Standard ventilatory monitoring data
compliance of the respiratory system
Time frame: During procedure (last 10 seconds of each ARM modality)
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)
Time frame: During procedure (last 10 seconds of each ARM modality)
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)
Time frame: During procedure (last 10 seconds of each ARM modality)
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)
Time frame: During procedure (last 10 seconds of each ARM modality)
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)
Time frame: During procedure (last 10 seconds of each ARM modality)
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
Time frame: During procedure (last 10 seconds of each ARM modality)
The secondary outcome measures are the evaluation of paraclinical data
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
Time frame: During procedure (last 10 seconds of each ARM modality)
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
Time frame: During procedure (last 10 seconds of each ARM modality)
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University Hospital, Clermont-Ferrand