Weaning From Nasal High Flow Therapy

NCT05210881 | Completed

• 1 other identifier: HLM_JDR11
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure. It has been shown to improve patient comfort, increase oxygenation and reduce need for intubation in some patients. The Respiratory Oxygenation (ROX) index has been established as a simple tool to help clinicians identify those patients who will succeed and those who will fail under nasal high flow and therefore predict the need for intubation. However, when nasal high flow therapy is successful, little is known as to how and when weaning of this device should be performed and what are the predictors of a safe withdrawal of the device. The objectives of this retrospective exploratory study are to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial; to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy.

Conditions

Respiratory Distress Syndrome, Adult; Acute Hypoxemic Respiratory Failure; Acute Respiratory Distress Syndrome; Weaning Failure

Keywords

nasal high flow oxygen; withdrawal from nasal high flow therapy; ROX index; acute hypoxemic respiratory failure; withdrawal trial

Outcome Measures

Primary Outcomes (1)

• Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal

  the ROX index the closest to the time at which nasal high flow is withdrawn will be recorded

  through each nasal high flow therapy, that lasts an average of 24hours

Secondary Outcomes (4)

• use of nasal high flow before weaning

  through each nasal high flow therapy, that lasts an average of 24 hours

• number of withdrawal trials

  through each nasal high flow therapy, that lasts an average of 24 hours

• number of patients who failed a withdrawal trial

  throughout study duration which is a one-year period

• number of patients who succeeded a withdrawal trial

  throughout study duration which is a one-year period

Eligibility Criteria

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

Study Population

ICU patients treated with nasal high flow therapy

You may qualify if:

• \- ICU patient treated with nasal high flow

You may not qualify if:

• age \< 18 years
• concomitant treatment with non-invasive ventilation
• acute hypercapnic respiratory failure

Sponsors & Collaborators

• Hôpital Louis Mourier: lead

Study Sites (1)

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Colombes, 92700, France

Location

Related Publications (3)

• Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.

  PMID: 32901374 BACKGROUND

• Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.

  PMID: 30576221 BACKGROUND

• Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.

  PMID: 31511996 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jean-Damien Ricard, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care Medicine, Head of ICU

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 27, 2022
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: August 31, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)