Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit (RHERA1)

February 22, 2017 updated by: Centre Hospitalier Universitaire, Amiens

Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit: a Randomized Study

Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.

In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.

The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:

  • An end-tidal plateau at 30 cmH20 for 30 seconds.
  • An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

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

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

sedated, intubated, mechanically ventilated adult patients

Description

Inclusion Criteria:

  • All sedated, intubated, mechanically ventilated adult patients (over-18) admitted to the surgical intensive care unit and equipped with a central venous catheter and an arterial catheter.
  • Good echogenicity
  • Social security coverage

Exclusion Criteria:

  • Pregnancy
  • Cardiac arrhythmia
  • Poor echogenicity
  • Legal guardianship or incarceration
  • Systolic blood pressure ≤90 mmHg
  • Respiratory distress
  • Patients admitted on an emergency basis (first 24 hours), i.e. not for elective surgery

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
Intervention / Treatment
30 cmH20 for 30 seconds

plateau pressure is hold on at 30 cmH20 pour 30 seconds. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later.

echocardiography - arterial oximetry
Device: echocardiography
• Prospective, simultaneous recording of the cardiac output (measured non-invasively via transthoracic echocardiography) and a number of parameters commonly monitored in the surgical intensive care unit (CVP, SBP/DBP/MBP).
Device: Arterial oximetry
measured by co-oximetry of a blood sample taken via the arterial catheter implemented for critical care
10 cmH20 above

plateau pressure is hold on at 10 cmH20 above. The cardiac output and the lung aeration is assessed by ultrasound measures at 3 times: before, at the end of the recruitment and 30 minutes later.

echocardiography - arterial oximetry
Device: echocardiography
• Prospective, simultaneous recording of the cardiac output (measured non-invasively via transthoracic echocardiography) and a number of parameters commonly monitored in the surgical intensive care unit (CVP, SBP/DBP/MBP).
Device: Arterial oximetry
measured by co-oximetry of a blood sample taken via the arterial catheter implemented for critical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variations in cardiac output induced by each type of AR manoeuvre
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Variations in PaO2 variations induced by each type of AR manoeuvre
Time Frame: Day 0
Day 0

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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

November 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (ESTIMATE)

June 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2015_843_0002

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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