Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05365854
Other study ID # RBPH 2021 GODET 3 (Charm ICU)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date March 1, 2024

Study information

Verified date February 2022
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone +33 473754963
Email llaclautre_perrier@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHU Clermont-ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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)
See also
  Status Clinical Trial Phase
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Recruiting NCT05535543 - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed NCT04695392 - Restore Resilience in Critically Ill Children N/A
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Completed NCT04534569 - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Completed NCT04078984 - Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
Completed NCT04451291 - Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure N/A
Not yet recruiting NCT06254313 - The Role of Cxcr4Hi neutrOPhils in InflueNza
Not yet recruiting NCT04798716 - The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19 Phase 1/Phase 2
Withdrawn NCT04909879 - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome Phase 2
Terminated NCT02867228 - Noninvasive Estimation of Work of Breathing N/A
Not yet recruiting NCT02881385 - Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation N/A
Completed NCT02545621 - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Withdrawn NCT02253667 - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients N/A
Completed NCT02889770 - Dead Space Monitoring With Volumetric Capnography in ARDS Patients N/A
Withdrawn NCT01927237 - Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide N/A
Completed NCT01504893 - Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A