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

NCT ID: NCT02805036

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Positive-Pressure Respiration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

echocardiography

Intervention Type 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

Intervention Type DEVICE

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

echocardiography

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DEVICE

Arterial oximetry

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel LORNE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2015_843_0002

Identifier Type: -

Identifier Source: org_study_id

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