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)

Adult Patients Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03282331
• Other study ID #: CHU-345
• Secondary ID: 2012-A00778-35
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2017
• Last updated: September 13, 2017
• Start date: June 2, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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