Post -Extubation Respiratory Failure

May 30, 2024 updated by: Mostafa Farouk, Cairo University

Different Oxygenation Modalities for Early Post Extubation Failure

comparing high flow nasal cannula , conventional oxygen tharapy and non invasive ventilation 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

Intervention / Treatment

Detailed Description

patients with respiratory failure either type I or type II planned for extubation will be divided into 3 groups post extubation :

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

Data of the patients will be collected for 28 days post-extubation and analysed

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11345
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 and conventional oxygen therapy
Other Names:
  • Non invasive ventilation
Active Comparator: High flow nasal cannula
A device of high flow nasal cannula giving 60 litres / min flow
Device: High flow nasal cannula
Device gives high flow oxygen comparable to non invasive ventilation and conventional oxygen therapy
Other Names:
  • Non invasive ventilation
Active Comparator: Non invasive ventilation
non invasive ventilation with IPAP and EPAP
Device: High flow nasal cannula
Device gives high flow oxygen comparable to non invasive ventilation and conventional oxygen therapy
Other Names:
  • 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
Time Frame: 7 days
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
Time Frame: 28 days
Duration of ICU stay and incidence of mortality
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Yasser Nassar, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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