Acute Respiratory Distress Syndrome Clinical Trial
— CHARM-ICUOfficial title:
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Intensive Care Unit Patients Under Mechanical Ventilation. A Pilot Physiological Study
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | CHU | Clermont-ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | During procedure (last 10 seconds of each ARM modality) | |
Secondary | 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) |
During procedure (last 10 seconds of each ARM modality) | |
Secondary | Standard hemodynamic monitoring data | heart rate | During procedure (last 10 seconds of each ARM modality) | |
Secondary | Invasive hemodynamic monitoring data | stroke volume (ml/min) | During procedure (last 10 seconds of each ARM modality) | |
Secondary | Invasive hemodynamic monitoring data | change in stroke volume | During procedure (last 10 seconds of each ARM modality) | |
Secondary | Standard ventilatory monitoring data | tidal volume (ml) | During procedure (last 10 seconds of each ARM modality) | |
Secondary | Standard ventilatory monitoring data | positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure, | During procedure (last 10 seconds of each ARM modality) | |
Secondary | Standard ventilatory monitoring data | respiratory rate | During procedure (last 10 seconds of each ARM modality) | |
Secondary | Standard ventilatory monitoring data | inspired oxygen fraction | During procedure (last 10 seconds of each ARM modality) | |
Secondary | Standard ventilatory monitoring data | compliance of the respiratory system | During procedure (last 10 seconds of each ARM modality) | |
Secondary | 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) |
During procedure (last 10 seconds of each ARM modality) | |
Secondary | 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) |
During procedure (last 10 seconds of each ARM modality) | |
Secondary | 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) |
During procedure (last 10 seconds of each ARM modality) | |
Secondary | 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) |
During procedure (last 10 seconds of each ARM modality) | |
Secondary | 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 |
During procedure (last 10 seconds of each ARM modality) | |
Secondary | The secondary outcome measures are the evaluation of paraclinical data | During the last 10 seconds of the recruitment maneuver, capnography will be recorded | During procedure (last 10 seconds of each ARM modality) | |
Secondary | 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 | During procedure (last 10 seconds of each ARM modality) |
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