Comparison of Hemodynamic Effect of 2 Methods for Alveolar Recruitment Maneuver in Anesthetized Patients (Hemorecrut)

July 11, 2017 updated by: University Hospital, Caen

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

During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar recruitment manoeuvres (ARM). Two methods for ARMs have been described. A sustained continuous positive airway pressure (CPAP) or a stepwise increase in PEEP.The transient increase in intrathoracic pressure during ARMs decreases venous return and increases pulmonary vascular resistance. This result in a decrease in right and left ventricular stroke volume (SV). Finally, the deleterious hemodynamic effects of ARMs may be exacerbated by hypovolemia, heart failure, and in patients with chronic treatment wich impedes cardiovascular responses to hypovolemia. At our best knowledge, there is no study which compared the hemodynamic effects of ARM using sustained CPAP or stepwise increase in PEEP. Consequently, the present study was designed to examine the hemodynamic effects of 2 ARM methods in anesthetized patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CPAP30
Alveolar recruitment maneuver with a continuous positive airway pressure (CPAP) at 30 cmH2O during 30 seconds
Procedure: abdominal or vascular surgery
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.
Procedure: abdominal or vascular surgery
Intermediate or high risk abdominal or vascular surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Caen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Luc Hanouz, M.D,Ph.D, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A15-D27-VOL.25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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