NCT04036175

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

June 17, 2019

Last Update Submit

July 29, 2019

Conditions

ICUExtubationNon-invasive VentilationHigh-Flow Nasal Oxygen TherapyRespiratory EffortWork of BreathingTidal Volume

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Respiratory parameters

    "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"

  • Respiratory parameters

    "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"

  • Respiratory parameters

    "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"

  • Respiratory parameters

    "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"

  • Hemodynamic parameters

    "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"

  • +1 more secondary outcomes

Study Arms (2)

Group 1

OTHER

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

Group 2

OTHER

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

Interventions

High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygenDEVICE

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%

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Poitiers

Poitiers, 86000, France

RECRUITING

Intensive reanimation

Poitiers, 86000, France

RECRUITING

Related Publications (2)

  • Arrive F, Le Pape S, Bruhn A, Pepin Lehalleur A, Beuvon C, Tuffet S, Etien E, Rambault L, Frat JP, Coudroy R, Thille AW. Physiological comparison of noninvasive ventilation and high-flow nasal oxygen on inspiratory efforts and tidal volumes after extubation: a randomized crossover trial. Crit Care. 2025 May 8;29(1):185. doi: 10.1186/s13054-025-05366-y.

    PMID: 40341100DERIVED

  • 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.

    PMID: 33661521DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Arnaud W. THILLE, PUPH

    Medecine intensive reanimation CHU Poitiers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud W. THILLE, PUPH

CONTACT

+33 5 49 44 38 54arnaud.thille@chu-poitiers.fr

Céline DELETAGE

CONTACT

celine.deletage@chu-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

July 29, 2019

Study Start

March 6, 2018

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

FR(2)