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

Positive-Pressure Respiration Clinical Trial

— RHERA1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805036
• Other study ID #: PI2015_843_0002
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: February 22, 2017
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Positive-Pressure Respiration

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variations in cardiac output induced by each type of AR manoeuvre		Day 0
Secondary	Variations in PaO2 variations induced by each type of AR manoeuvre		Day 0