- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03215329
Comparison of Hemodynamic Effect of 2 Methods for Alveolar Recruitment Maneuver in Anesthetized Patients (Hemorecrut)
Comparison of Stroke Volume Variation During Alveolar Recruitment With Stepwise Increase in Positive End Expiratory Pressure and Continuous Positive Airway Pressure (30cmH2O During 30 Seconds) in Anesthetised Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-centre prospective observational study performed in operating rooms of the university hospital of Caen.
Inclusion criteria were adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the european guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor Patients less than 18 year-old, adults under protection, pregnant women, patients with atrial fibrillation, history of right ventricular dysfunction, known left ventricular ejection fraction < 30%, or preoperative pulmonary disease were excluded.
After intravenous line placement and monitoring (IntelliVue MP70 Philips HealthCare, Amsterdam, The Netherlands) with continuous 5-lead electrocardiography, pulse oximetry, and bispectral index, after local anaesthesia a radial intra-arterial catheter was inserted and connected to a pressure transducer zeroed at the intersection of the mid axillary line and the fifth intercostal space. Arterial pressure and pulse pressure variation (PPV) were continuously displayed on the IntelliVue MP70 monitor. After a 3 to 5 min preoxygenation, anaesthesia was induced and maintained using target-controlled total intravenous anaesthesia with propofol and remifentanil. If a neuromuscular blocking agent was administered its effect was monitored by accelerometry at the thumb following Train-of-Four stimulations of the ulnar nerve repeated every 30 seconds. Following orotracheal intubation; patients were ventilated with controlled ventilation mode (inspired Oxygen fraction 40%, tidal volume: 8ml.kg-1, PEEP at +5 to +8 cmH2O, inspiratory to expiratory ratio of ½, respiratory rate between 10 and 15 min-1 to maintain an end-tidal carbon dioxide partial pressure of 30 to 35 mmHg). An oesophageal Doppler probe connected to its monitor was inserted after tracheal intubation (CardioQ-ODM, Deltex Medical, UK). Then, a fluid challenge was performed with 250 ml of colloid or crystalloid at the discretion of anaesthesiologist and repeated if the SV increased by more than 10%.
The first ARM was performed after orotracheal intubation and SV optimisation. Two preset ARM were available on the anaesthesia respirator: CPAP at 30 cmH2O for 30 seconds (CPAP30) and a stepwise increase and decrease in PEEP (PEEPsteps). The choice of the ARM was left at the discretion of the attending anaesthesiologist.
Heart rate, arterial pressure (systolic, diastolic, mean), PPV, pulse oximetry, cardiac index (CI), SV, peak velocity (PV), corrected flow time (FTc, averaged across 10 successive measurements), and bispectral index were recorded by an independent observer before the ARM, during the ARM at the nadir of SV variation, and 1 (after1) and 3 (after3) min after the end of the ARM.
Definitions of outcomes The primary outcome was the absolute variation of SV during ARM. The secondary outcomes were: variation of arterial blood pressure (mean, systolic and diastolic), PPV, CI, PV, FTc, and pulse oximetry
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Caen, France, 14000
- Recruiting
- CHU de Caen
-
Contact:
- Jean-Luc Hanouz, M.D.,Ph.D.
- Email: hanouz-jl@chu-caen.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients aged 18 year and above, American Society of Anesthesiologists physical status II to IV, scheduled for intermediate and high risk abdominal and vascular surgery (as defined by the guidelines on non-cardiac surgery: cardiovascular assessment and management), and equipped with a radial arterial catheter and transoesophageal doppler monitor
Exclusion Criteria:
- Patients less than 18 year-old, adults under protection, pregnant women, patients with atrial fibrillation, history of right ventricular dysfunction, known left ventricular ejection fraction < 30%, or preoperative pulmonary disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CPAP30
Alveolar recruitment maneuver with a continuous positive airway pressure (CPAP) at 30 cmH2O during 30 seconds
|
Intermediate or high risk abdominal or vascular surgery
|
PEEPsteps
Alveolar recruitment maneuver with a stepwise increase and decrease in positive end expiratory pressure from 5 to 20 cmH2O.
|
Intermediate or high risk abdominal or vascular surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in stroke volume
Time Frame: before and during the alveolar recruitment maneuver
|
stroke volume measured by transoesophageal doppler probe
|
before and during the alveolar recruitment maneuver
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiac index
Time Frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
|
cardiac index measured by transoesophageal doppler probe
|
before, during, 1 and 3 min after the alveolar recruitment maneuver
|
pulse pressure variation
Time Frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
|
pulse pressure variation displayed on the hemodynamic monitor
|
before, during, 1 and 3 min after the alveolar recruitment maneuver
|
arterial pressure
Time Frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
|
arterial pressure : systolic, diastolic and mean
|
before, during, 1 and 3 min after the alveolar recruitment maneuver
|
heart rate
Time Frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
|
heart rate displayed on the hemodynamic monitor
|
before, during, 1 and 3 min after the alveolar recruitment maneuver
|
peak velocity
Time Frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
|
peak velocity measured by transoesophageal doppler probe
|
before, during, 1 and 3 min after the alveolar recruitment maneuver
|
Corrected Flow Time
Time Frame: before, during, 1 and 3 min after the alveolar recruitment maneuver
|
Corrected Flow Time measured by transoesophageal doppler probe
|
before, during, 1 and 3 min after the alveolar recruitment maneuver
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Luc Hanouz, M.D,Ph.D, University Hospital, Caen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A15-D27-VOL.25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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