Pos -Extubation High Flow Nasal Cannula

Post Extubation High Flow Nasal Cannula Versus Conventional Oxygen Therapy in Extubation Failure.

comparing high flow nasal cannula & conventional oxygen tharapy in post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome &28 days mortality

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Device: High flow nasal cannula

Detailed Description

patients with respiratory failure either type I or type II planned for extubation will be divided into 2 groups post extubation :

Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute group II: will receive nasal cannula up to 10 litres / minute

Data of the patients will be collected for 28 days postextubation and analysed

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11345
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• respiratory failure type I and Type II

Exclusion Criteria:

• Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High flow nasal cannula; A device og high flow nasal cannula giving 60 litres / min	Device: High flow nasal cannula; Device gives high flow oxygen comparable to non invasive ventilation
Placebo Comparator: Conventional oxygen; Nasal cannula giving oxygen up to 10 litres / minute	Device: High flow nasal cannula; Device gives high flow oxygen comparable to non invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with post extubation respiratory failure	Number of participants with post extubation hypoxemia with or without hypercapnea	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ICU stay and mortality	Duration of ICU stay and incidence of mortality	28 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Yasser Nassar, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: MS-313-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No