NCT04657796

Brief Summary

evaluate the Efficacy of high flow nasal oxygen as a weaning strategy in mechanically ventilated patients with respiratory failure.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

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

First Submitted

Initial submission to the registry

October 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2023

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

October 4, 2020

Last Update Submit

December 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Is patient outcome in terms of survival or death at discharge.

    evaluate the Efficacy of high flow nasal oxygen as a weaning strategy in mechanically ventilated patients with respiratory failure as regarding Hospitalization ,complications, oxygenation , reintubation rate, mortality rate.

    through study completion average 7 days.

Secondary Outcomes (1)

  • Duration of ICU stay through study completion average 7 days ,Adverse events.

    through study completion average 7 days.

Interventions

use of high flow nasal cannula as a weaning mode from invasive mechanical ventilation to deliver oxygen

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patient in respiratory ICU who mechanically intubated will be enrolled in study by using high flow nasal oxygen as a weaning strategy.

You may qualify if:

  • All adult patients who were admitted to our ICU requiring endotracheal intubation (ETI), were eligible for the study.

You may not qualify if:

  • Non-intubated patients or those with tracheostomy were excluded from the study.
  • those having neurological alteration unrelated to hypercapnoeic encephalopathy, cranio-facial deformity, upper airway obstruction, cardiogenic pulmonary edema, cardiogenic shock, acute myocardial infarction, pneumothorax, pulmonary neoplasm, pulmonary thromboembolism, gastrointestinal bleeding, and post-operative respiratory failure.
  • Patients less than 18 y.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11.

    PMID: 26969671BACKGROUND
  • Helviz Y, Einav S. A Systematic Review of the High-flow Nasal Cannula for Adult Patients. Crit Care. 2018 Mar 20;22(1):71. doi: 10.1186/s13054-018-1990-4.

    PMID: 29558988BACKGROUND
  • Drake MG. High-Flow Nasal Cannula Oxygen in Adults: An Evidence-based Assessment. Ann Am Thorac Soc. 2018 Feb;15(2):145-155. doi: 10.1513/AnnalsATS.201707-548FR.

Study Officials

  • Suzan Sl Sayed, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Hamed Fr Qenawy, Bachelor

CONTACT

Doaa Mo Magdy, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 4, 2020

First Posted

December 8, 2020

Study Start

December 5, 2020

Primary Completion

October 5, 2022

Study Completion

December 4, 2023

Last Updated

December 8, 2020

Record last verified: 2020-12