NCT05577221

Brief Summary

Detection and relief of dyspnea in mechanically ventilated patients is a priority. Optimization of mechanical ventilation settings is unfortunately often insufficient to relieve dyspnea in patients entering the weaning process. Pharmacological treatments are effective but their use is likely to delay separation with the ventilator. Promoting the development of non-pharmacological interventions is therefore an interesting avenue. The hypothesis is that the application of high-flow humidified nasal air in orotracheally intubated patients can decrease the work of breathing and relieve dyspnea at the time of weaning from mechanical ventilation. Patients will be exposed to stepwise increase in high flow nasal air (0 L/min, 30 L/min, 50 L/min and 70 L/min) before to undergo a 60 minutes spontaneous breathing trial. During the protocol, dyspnea, inspiratory effort, respiratory drive, respiratory muscles electromyogram (EMG) and patient's comfort will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

September 26, 2022

Last Update Submit

August 9, 2024

Conditions

Acute Respiratory Failure

Keywords

DyspneaWeaningMechanical ventilationHigh flow nasal air

Outcome Measures

Primary Outcomes (2)

  • The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.

    Dyspnea Numerical Rating Scale from 0 to 10

    at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

  • The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.

    Mechanical Ventilation Respiratory Distress Observational Scale

    at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

Secondary Outcomes (4)

  • inspiratory effort

    at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

  • respiratory drive

    at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

  • respiratory muscles activity

    at 15 min to inclusion, compare to, 35, 55, 75, 105 and 135 min

  • patient comfort

    at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

Study Arms (1)

Collection of physiological parameters

EXPERIMENTAL

Installation of the high-flow humidified nasal oxygen therapy device and variation of the inspiratory flow rate (0 L/min, 30 L/min, 50 L/min and 70 L/min) then the weaning test will be performed. During each step of the protocol (= each variation of the inspiratory flow), the intensity of dyspnea will be collected, the esophageal pressure will be measured, the respiratory drive (P0.1) will be measured, the EMG of the respiratory muscles will be measured and the comfort will be measured. Each step lasts about 15 minutes with 5 minutes of wash-out before the next step. Once the 4 steps will be conducted, the weaning test will be performed (without wash-out), for a duration of one hour, 30 minutes with high flow humidified nasal oxygen (50 L/min) and 30 minutes without (both steps being randomized. The whole protocol will last 2h15.

Device: High Flow Nasal Air

Interventions

High Flow Nasal AirDEVICE

Administration of air at high flow by using a high flow nasal oxygenation (FiO2 21%) device

Also known as: High Flow Nasal Cannula
Collection of physiological parameters

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • orotracheal intubation
  • Decision to initiate a spontaneous breathing trial by the clinical team
  • Visual analogic scale of dyspnea \> 3/10
  • Informed consent to participate
  • Patient covered by the national health

You may not qualify if:

  • No esophageal probe in place
  • Extubation planned without a spontaneous breathing trial
  • Glasgow coma scale\< 12
  • Patient's refusal
  • No coverage by the national health insurance
  • Patient under legal protection of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical ICU R3S, Pitié-Salpétriêre Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 13, 2022

Study Start

February 17, 2023

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations

FR(1)