High Flow Nasal Cannula in Respiratory Failure With Hypoxia - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Respiratory Failure With Hypoxia

Intervention / Treatment

Device: High Flow Nasal Cannula

Detailed Description

Acute respiratory failure is a main cause of IMV and admission to intensive care unit (ICU){1}.

The day of extubation is a critical time during an intensive care unit (ICU) stay because in case of postextubation failure {2},which reach to 25 - 40% from extubated patient associated with VAP and barotrauma, mortality rate and hospital stay will increase , we use Adjuvant oxygen therapy to prevent these undesirable event like COT ,NIV and High-flow nasal cannula (HFNC) which can be used as an initial weaning strategy from IMVdue to its physiologic benefits [3-4].

HFNC devices supply between 30 and 60 L/min of a controlled mixture of actively warmed (32-37 °C) and humidified (up to 100% relative humidity) oxygen and air through modified nasal prongs. producing {5-6-7}:

moderate positive end-expiratory pressure (PEEP) .
HFNC might help prevent extubation failure through different

Mechanisms:

First, the controlled oxygen concentration may reduce transient hypoxemic episodes .
Second, the high flow washes the nasopharyngeal dead space, thus reducing CO2 re-breathing; this effect reduces respiratory rate and minute ventilation .
Third, the small amount of PEEP may reduce lung collapse . c)enabling better gas exchange and reduced work of breathing. d)in patients with chronic obstructive pulmonary disease (COPD), this level of PEEP may counterbalance auto PEEP, further reducing the work of breathing.

e) humidification may improve mucus drainage and reduce mucus retention, alleviating the associated atelectasis.

Study Type

Observational

Enrollment (Anticipated)

84

Contacts and Locations

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

Study Contact

Name: Hamed Fr Qenawy, Bachelor
Phone Number: 01061812045
Email: hamedfarrag216@gmail.com

Study Contact Backup

Name: Doaa Mo Magdy, Lecturer
Phone Number: 01006261010
Email: doaamagdy_2020@yahoo.com

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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is patient outcome in terms of survival or death at discharge. Time Frame: through study completion average 7 days.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of ICU stay through study completion average 7 days ,Adverse events. Time Frame: through study completion average 7 days.	evaluate efficacy of high flow nasal cannula on duration of hospital stay, complications rate.	through study completion average 7 days.

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

Study Director: Suzan Sl Sayed, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 5, 2020

Primary Completion (Anticipated)

October 5, 2022

Study Completion (Anticipated)

December 4, 2023

Study Registration Dates

First Submitted

October 4, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)