NCT04385823

Brief Summary

Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 11, 2020

Last Update Submit

May 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in ROX index

    values of ROX index during ICU stay

    from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Secondary Outcomes (7)

  • NHF failure

    from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

  • NHF flow

    from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

  • NHF inspired fraction in oxygen

    from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

  • oxygenation

    from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

  • respiratory status

    from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

  • +2 more secondary outcomes

Interventions

patients admitted to the ICU for Covid-19-related acute hypoxemic respiratory failure treated with nasal high flow

Eligibility Criteria

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

all adult patients admitted to the ICU with proven Covid-19 pneumonia and acute hypoxemic respiratory failure requiring supplemental oxygen administered via NHF

You may qualify if:

  • Covid-19 pneumonia
  • acute hypoxemic respiratory failure
  • need for nasal high flow therapy as first line therapy
  • admission to intensive care

You may not qualify if:

  • intubation prior to NHF therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Colombes, 92700, France

Location

Related Publications (2)

  • 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: 30576221BACKGROUND
  • Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.

    PMID: 27481760BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory SyndromePneumonia, Viral

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumoniaLung Diseases

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
Head Medico-surgical ICU

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 13, 2020

Study Start

March 1, 2020

Primary Completion

May 4, 2020

Study Completion

May 4, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations