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)

NCT03282331 | Unknown

• 2 other identifiers: CHU-3452012-A00778-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

Study Arms (3)

standard oxygenation

EXPERIMENTAL

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

High flow nasal oxygen therapy

OTHER

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

NonInvasive Ventilation

OTHER

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

Interventions

Standard oxygenation PROCEDURE

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

standard oxygenation

High flow nasal oxygenation PROCEDURE

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 oxygen therapy

noninvasive ventilation PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient refusal
• intubation for other causes (excluding hypoxemia)
• impossibility to measure pulse oxymetry value
• contraindication for NIV : vomiting
• NIV intolerance
• cardiac arrest during intubation

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Thomas GODET

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking Details: open
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 13, 2017
• Study Start: June 2, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

FR (1)