Blood Pressure Clinical Trial
— CHARM-BlocOfficial title:
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients: A Physiological Study
Verified date | June 2023 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 20 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
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 MRA 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 | last 10 seconds of each ARM modality | |
Secondary | Standard hemodynamic monitoring data | blood pressure, mean arterial pressure, | last 10 seconds of each ARM modality | |
Secondary | Standard hemodynamic monitoring data | heart rate | last 10 seconds of each ARM modality | |
Secondary | Invasive hemodynamic monitoring data | stroke volume change in stroke volume | last 10 seconds of each ARM modality | |
Secondary | Invasive hemodynamic monitoring data | change in stroke volume | last 10 seconds of each ARM modality | |
Secondary | Evaluation of standard ventilatory monitoring data | tidal volume (ml) | last 10 seconds of each ARM modality | |
Secondary | Evaluation of standard ventilatory monitoring data | positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure | last 10 seconds of each ARM modality | |
Secondary | Evaluation of standard ventilatory monitoring data | respiratory rate, | last 10 seconds of each ARM modality | |
Secondary | Evaluation of standard ventilatory monitoring data | inspired oxygen fraction, | last 10 seconds of each ARM modality | |
Secondary | Evaluation of standard ventilatory monitoring data | compliance of the respiratory system | last 10 seconds of each ARM modality | |
Secondary | Electro-impedancemetry data | Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
COV : Center Of Ventilation and GI : Global Inhomogeneity index |
last 10 seconds of each ARM modality | |
Secondary | Electro-impedancemetry data | Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
TIV : Tidal Impedance Variation |
last 10 seconds of each ARM modality | |
Secondary | Electro-impedancemetry data | Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
RVD : Regional Ventilation Delay |
last 10 seconds of each ARM modality | |
Secondary | Electro-impedancemetry data | Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
EELI : End Expiratory Lung Impedance |
last 10 seconds of each ARM modality | |
Secondary | Electro-impedancemetry data | Analysis of pulmonary aeration will be performed using the non-invasive technique of tomographic electroimpedancemetry 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 |
last 10 seconds of each ARM modality | |
Secondary | Paraclinics data | During the last 10 seconds of the recruitment maneuver, capnography will be recorded | last 10 seconds of each ARM modality | |
Secondary | Paraclinics data | During the last 10 seconds of the recruitment maneuver, SpO2 will be recorded | last 10 seconds of each ARM modality |
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