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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)

Primary Purpose

Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard oxygenation
High flow nasal oxygenation
noninvasive ventilation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Patients focused on measuring Preoxygenation, Intubation, Electrical Impedance Tomography, Lung aeration, Alveolar recruitment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

standard oxygenation

High flow nasal oxygen therapy

NonInvasive Ventilation

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

evolution of lung aeration evaluated by electrical impedance tomography during the preoxygenation for intubation of hypoxemic patients and the arterial blood oxygenation

Secondary Outcome Measures

electrical impedance tomography related indexes
Lung inhomogeneity index
End expiratory lung impedance
Center of Ventilation
Tidal Volume
pulse oxymetry value
Partial pressure of arterial oxygen (PaO2)
Regurgitation rate
oxyhemoglobin desaturation below 80 %

Full Information

First Posted
September 4, 2017
Last Updated
September 13, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03282331
Brief Title
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)
Acronym
MORPHEIT
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200), Patient Covered by French Health Care System
Keywords
Preoxygenation, Intubation, Electrical Impedance Tomography, Lung aeration, Alveolar recruitment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking Description
open
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard oxygenation
Arm Type
Experimental
Arm Description
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
Arm Title
High flow nasal oxygen therapy
Arm Type
Other
Arm Description
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
Arm Title
NonInvasive Ventilation
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard oxygenation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
High flow nasal oxygenation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
noninvasive ventilation
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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)
Title
Lung inhomogeneity index
Time Frame
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
End expiratory lung impedance
Time Frame
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
Center of Ventilation
Time Frame
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
Tidal Volume
Time Frame
at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
pulse oxymetry value
Time Frame
at day 1 (at 5 minutes and at 30 minutes after intubation)
Title
Partial pressure of arterial oxygen (PaO2)
Time Frame
at day 1
Title
Regurgitation rate
Time Frame
at day 1
Title
oxyhemoglobin desaturation below 80 %
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas GODET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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)

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