Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial) (MORPHEIT)

September 13, 2017 updated by: University Hospital, Clermont-Ferrand

Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Preoxygenation before endotracheal intubation in the ICU is a prerequisite to limit complications, ranging from desaturation, severe hypoxemia and bradycardia with potential cardiac arrest and death. International recommendations suggest the use of non-invasive ventilation (NIV) technique whenever possible. High flow nasal cannula (HFNC) has recently gained growing interest in the ICU as a treatment of acute respiratory failure, to improve extubation success and as a preoxygenation device before endotracheal intubation. Conflicting results have been published.

The PREONIV study was designed to compare NIV, HFNC and conventional preoxygenation with valve bag mask for the preoxygenation before endotracheal intubation.

Investigator propose to add a lung morphology analysis during preoxygenation. Electrical impedance tomography (EIT) is a non invasive tool which analyse lung aeration variations via the evolution of local thoracic impedances with electrical loop circulating around a thoracic belt with electrodes.

The hypothesis is that the technique of preoxygenation might correlate with oxygen desaturation and potential intubation related complications (PREONIV study). Moreover lung morphology modifications evaluated by EIT might be associated with the preoxygenation technique (MORPHEIT study).

Investigator wish to asses lung morphological modifications evaluated by EIT during preoxygenation in a prospective non blinded randomized fashion.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • adults patients

    • requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
    • patient covered by french health care system
    • patient included in Hopital Estaing, Clermont-Ferrand

Exclusion Criteria:

  • • patient refusal

    • intubation for other causes (excluding hypoxemia)
    • impossibility to measure pulse oxymetry value
    • contraindication for NIV : vomiting
    • NIV intolerance
    • cardiac arrest during intubation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard oxygenation
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Procedure: Standard oxygenation
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Other: High flow nasal oxygen therapy
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Procedure: High flow nasal oxygenation
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Other: NonInvasive Ventilation
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Procedure: noninvasive ventilation
Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evolution of lung aeration evaluated by electrical impedance tomography during the preoxygenation for intubation of hypoxemic patients and the arterial blood oxygenation
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
electrical impedance tomography related indexes
Time Frame: at day 1 (before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
at day 1 (before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Lung inhomogeneity index
Time Frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
End expiratory lung impedance
Time Frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Center of Ventilation
Time Frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Tidal Volume
Time Frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
pulse oxymetry value
Time Frame: at day 1 (at 5 minutes and at 30 minutes after intubation)
at day 1 (at 5 minutes and at 30 minutes after intubation)
Partial pressure of arterial oxygen (PaO2)
Time Frame: at day 1
at day 1
Regurgitation rate
Time Frame: at day 1
at day 1
oxyhemoglobin desaturation below 80 %
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-345
  • 2012-A00778-35 (Registry Identifier: 2012-A00778-35)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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