Post -Extubation Respiratory Failure

NCT ID: NCT04441736

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-20

Study Completion Date

2020-05-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High flow nasal cannula

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

Group Type ACTIVE_COMPARATOR

High flow nasal cannula

Intervention Type DEVICE

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

Conventional oxygen

Nasal cannula giving oxygen up to 10 litres / minute

Group Type PLACEBO_COMPARATOR

High flow nasal cannula

Intervention Type DEVICE

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

Non invasive ventilation

non invasive ventilation with IPAP and EPAP

Group Type ACTIVE_COMPARATOR

High flow nasal cannula

Intervention Type DEVICE

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

Interventions

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High flow nasal cannula

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

Intervention Type DEVICE

Other Intervention Names

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Non invasive ventilation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Farouk

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasser Nassar, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Medicine

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-313-2019

Identifier Type: -

Identifier Source: org_study_id

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