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

Adult Patients Clinical Trial

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)

Status Recruiting

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT03282331
Study type	Interventional
Source	University Hospital, Clermont-Ferrand
Contact	Patrick LACARIN
Phone	0473751195
Email	placarin@chu-clermontferrand.fr
Status	Recruiting
Phase	N/A
Start date	June 2, 2016
Completion date	October 1, 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.