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 Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200), Patient Covered by French Health Care System

Intervention / Treatment
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* Procedure: Standard oxygenation
* Procedure: High flow nasal oxygenation
* Procedure: noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard oxygenation<br>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<br>* 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<br>|
| Other: High flow nasal oxygen therapy<br>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<br>* 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<br>|
| Other: NonInvasive Ventilation<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoxygenation, Intubation, Electrical Impedance Tomography, Lung aeration, Alveolar recruitment