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

NCT02805036 | Completed

• 1 other identifier: PI2015_843_0002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Positive-Pressure Respiration

Keywords

alveolar recruitment; stroke volume/physiology; cardiac output/physiology

Outcome Measures

Primary Outcomes (1)

• Variations in cardiac output induced by each type of AR manoeuvre

  Day 0

Secondary Outcomes (1)

• Variations in PaO2 variations induced by each type of AR manoeuvre

  Day 0

Study Arms (2)

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; Device: Arterial oximetry

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; Device: Arterial oximetry

Interventions

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).

10 cmH20 above; 30 cmH20 for 30 seconds

Arterial oximetry DEVICE

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

10 cmH20 above; 30 cmH20 for 30 seconds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

sedated, intubated, mechanically ventilated adult patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Emmanuel LORNE, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FR (1)