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

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ClinicalTrials.gov Identifier: NCT02805036
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

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.

Condition or disease Intervention/treatment
Positive-Pressure Respiration Device: echocardiography Device: Arterial oximetry

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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




Primary Outcome Measures :
  1. Variations in cardiac output induced by each type of AR manoeuvre [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Variations in PaO2 variations induced by each type of AR manoeuvre [ Time Frame: Day 0 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
sedated, intubated, mechanically ventilated adult patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805036


Locations
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France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Emmanuel LORNE, MD, PhD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02805036    
Other Study ID Numbers: PI2015_843_0002
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Centre Hospitalier Universitaire, Amiens:
alveolar recruitment
stroke volume/physiology
cardiac output/physiology