NCT04141956

Brief Summary

Patients with one or more organ failure (heart, lung) require hospitalization in intensive care where these failures can be managed. Nearly 30% of patients in intensive care units are hospitalized for acute respiratory distress (lung failure). This failure occurs in about 20% of postoperative patient, but it can also occur in the context of a pathology specific to the lung or after weaning of mechanical ventilation. It is therefore interesting to develop several techniques to provide oxygen to these patients with the aim in particular to avoid the use of intubation (insertion of a tube into the trachea to achieve artificial ventilation). For the past ten years, High-Flow Nasal Canula (HFNC) has developed. This technique reduces the need for intubation but the studies are contradictory, however they agree on its ease of use and the few risks associated with it. The principle of this technique is to deliver a humidified and heated gas mixture at a high rate through large nasal cannula. The advantage of this device is its non-invasive and the possibility of administering a large amount of oxygen. There is a certain craze for this oxygenation technique despite few scientific studies in the literature. However, it requires the expertise of the medical and paramedical team so as not to delay intubation. The investigators propose to carry out an observational study (without any modification of the usual practices) with epidemiological aim in order to make an inventory of the modes of use of the HFNC, in particular on its frequency of use and on its duration of use per patient hospitalized in intensive care. The investigators will recruit all HFNC patients in intensive care units (20 centers) (30 patients / center): 15 after weaning of mechanical ventilation and 15 others for other reasons. Patients will be followed every day and up to 48 hours after removal of the HFNC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

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

October 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

November 2, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

October 25, 2019

Last Update Submit

March 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of nasal High-Flow Nasal Cannula (HFNC) Oxygen therapy in patients admitted to intensive care

    Incidence defined by: the ratio of the number of patients under HFNC on the number of patients admitted to intensive care during the period of inclusion.

    28 days after enrollment

Interventions

Incidence of nasal High Flow Nasal Cannula (HFNC) Oxygen therapy in patients admitted to intensive care.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults' patients, admitted to intensive care units treated with HFNC (indication is to discretion of doctor). For example : Acute Hypoxemic Respiratory Failure, Postoperative Respiratory Failure or systematic when weaning mechanical ventilation.

You may qualify if:

  • all adults' patients, admitted to intensive care units treated with HFNC (indication is to discretion of doctor).

You may not qualify if:

  • HFNC use for Preoxygenation and Apneic Oxygenation for Intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chu Jean Minjoz Besancon

Besançon, 25030, France

Location

CHU CAEN

Caen, 14033, France

Location

Polyclinique Du Cotentin

Cherbourg, 50100, France

Location

Centre Hospitalier Du Mans

Le Mans, 72037, France

Location

CHU de Nantes

Nantes, France

Location

Chru Orleans

Orléans, 45067, France

Location

CH de SAINT NAZAIRE

Saint-Nazaire, 44606, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Chru Bretonneau - Tours

Tours, 37044, France

Location

Centre Hospitalier Bretagne-Atlantique -Site de Vannes

Vannes, 56017, France

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 28, 2019

Study Start

November 2, 2019

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations