NCT04441736

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

February 20, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

June 10, 2020

Last Update Submit

May 30, 2024

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Number of participants with post extubation respiratory failure

    Number of participants with post extubation hypoxemia with or without hypercapnea

    7 days

Secondary Outcomes (1)

  • Rate of ICU stay and mortality

    28 days

Study Arms (3)

High flow nasal cannula

ACTIVE COMPARATOR

A device of high flow nasal cannula giving 60 litres / min flow

Device: High flow nasal cannula

Conventional oxygen

PLACEBO COMPARATOR

Nasal cannula giving oxygen up to 10 litres / minute

Device: High flow nasal cannula

Non invasive ventilation

ACTIVE COMPARATOR

non invasive ventilation with IPAP and EPAP

Device: High flow nasal cannula

Interventions

High flow nasal cannulaDEVICE

Device gives high flow oxygen comparable to non invasive ventilation and conventional oxygen therapy

Also known as: Non invasive ventilation
Conventional oxygenHigh flow nasal cannulaNon invasive ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • respiratory failure type I and Type II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Giza, 11345, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Yasser Nassar, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 22, 2020

Study Start

February 20, 2019

Primary Completion

May 30, 2020

Study Completion

May 31, 2020

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)