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Completed

NCT Number: NCT02805036

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

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.

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Key information

Conditions

Positive-Pressure Respiration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Device
  • 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).

Arterial oximetry

Device

measured by co-oximetry of a blood sample taken via the arterial catheter implemented for critical care

Primary outcomes

  1. Variations in cardiac output induced by each type of AR manoeuvre

    Time frame: Day 0

Secondary outcomes

  1. Variations in PaO2 variations induced by each type of AR manoeuvre

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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

Acronym: RHERA1

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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