NCT03282331

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2016-06-02
• Primary completion: 2017-09-01
• Completion: 2017-10-01
• First posted: 2017-09-13
• Last updated: 2017-09-14

Locations

1 site across 1 country: France