CHU
Clermont-Ferrand, 63000, France
NCT Number: NCT05365113
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
In practice, after induction of general anesthesia and intubation, patients will be conditioned with the recommended monitoring (arterial catheter, central venous catheter, and transpulmonary thermodilution).
Once conditioning is complete, optimization of blood volume will be performed with volumetric expansions (250 mL of Ringer lactate) to achieve a change in stroke volume of less than 10%, as recommended (RFE SFAR 2013 - Perioperative Vascular Filling Strategy). The patient will then be randomized to one of the following groups: [ extended sigh then CPAP ] or [ CPAP then extended sigh ] (random order of ARMs - each patient becoming their own control). In order to homogenize the settings, the mechanical ventilation will be standardized with in particular the use of a PEEP of 6 cmH2O before inclusion and between the ARMs (for a duration of at least 10 minutes in each case).
Hemodynamic values will be recorded during the last 10 seconds of each procedure. Once the two ARMs have been performed, the rest of the management will then be left to the discretion of the practitioner in charge of the patient.
The included patient will be managed according to the recommendations at the time of the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: last 10 seconds of each ARM modality
Cardiac output (l/min) will be measured by invasive monitoring during the last 10 seconds of each recruitment maneuver
Time frame: last 10 seconds of each ARM modality
blood pressure, mean arterial pressure,
Time frame: last 10 seconds of each ARM modality
heart rate
Time frame: last 10 seconds of each ARM modality
stroke volume change in stroke volume
Time frame: last 10 seconds of each ARM modality
change in stroke volume
Time frame: last 10 seconds of each ARM modality
tidal volume (ml)
Time frame: last 10 seconds of each ARM modality
positive end-expiratory pressure (PEEP), peak pressure, plateau inspiration pressure, driving pressure
Time frame: last 10 seconds of each ARM modality
respiratory rate,
Time frame: last 10 seconds of each ARM modality
inspired oxygen fraction,
Time frame: last 10 seconds of each ARM modality
compliance of the respiratory system
Time frame: last 10 seconds of each ARM modality
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
Time frame: last 10 seconds of each ARM modality
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
Time frame: last 10 seconds of each ARM modality
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
Time frame: last 10 seconds of each ARM modality
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
Time frame: last 10 seconds of each ARM modality
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
Time frame: last 10 seconds of each ARM modality
During the last 10 seconds of the recruitment maneuver, capnography will be recorded
Time frame: last 10 seconds of each ARM modality
During the last 10 seconds of the recruitment maneuver, SpO2 will be recorded
University Hospital, Clermont-Ferrand
Other
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients: A Physiological Study
Acronym: CHARM-Bloc
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05800808
Cardiac Output, Edema
Riverside, California, United States
View Trial DetailsNCT05779683
Cardiac Output, Hemodynamic Monitoring
Winston-Salem, North Carolina, United States
View Trial DetailsNCT04685733
Blood Pressure, Cardiac Output
Charlottesville, Virginia, United States
View Trial DetailsNCT04068233
AV Block, Arrhythmias, Cardiac
Linz, Upper Austria, Austria
View Trial Details