Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU. (OVNI)

Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study

This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.

Study Overview

• Status: Unknown
• Conditions: Extubation; Work of Breathing; ICU; Non-invasive Ventilation; Tidal Volume; Respiratory Effort; High-Flow Nasal Oxygen Therapy
• Intervention / Treatment: Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • CHU Poitiers
    • Contact: Arnaud W THILLE, Pr; Phone Number: 05 49 44 38 54; Email: arnaud.thille@chu-poitiers.fr
  • Poitiers, France, 86000
    • Recruiting
    • Intensive reanimation
    • Contact: Arnaud THILLE; Phone Number: +33 5 49 44 38 54
    • Contact: Jean-Pierre FRAT; Phone Number: +33 5 49 44 38 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Minimum age: 18 years
• planned extubation decided by the physician in charge of the patient after success of weaning trial
• patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease
• Hypoxemia defined by PaO2/FiO2 < 300 mmHg under mechanical ventilation before extubation

Exclusion Criteria:

• Duration of mechanical ventilation prior to extubation < 24h
• Contraindication to NIV
• Contraindication to nasogastric tube
• Do-not-reintubated order at time of extubation
• People under legal protection
• Opposition to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Group 1; Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition)	Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen; Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2>= 92%
OTHER: Group 2; Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition)	Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen; Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2>= 92%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient respiratory effort and tidal volume (Vt)	Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography	1h20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory parameters	respiratory rate (FR bt/min)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters	saturation (SpO2 in %)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters	transcutaneous CO2 pressure (PCO2 in mm Hg)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters	transpulmonary pressure (cm H2O)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Hemodynamic parameters	Systolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Comfort evaluation	comfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort)	"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Arnaud W. THILLE, PUPH, Medecine intensive reanimation CHU Poitiers

Publications and helpful links

General Publications

• Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2018
• Primary Completion (ANTICIPATED): March 6, 2020
• Study Completion (ANTICIPATED): March 6, 2020

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (ACTUAL): July 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2017-A02838-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No