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Clinical Trials/CTRI/2024/08/071807
CTRI/2024/08/071807
Completed
Phase 3 4

Effect of High Flow Nasal Oxygenation versus conventional oxygen therapy in preventing reintubation after planned extubation in ICU patients

AIIMS PATNA1 site in 1 country108 target enrollmentStarted: September 15, 2024Last updated:

Overview

Phase
Phase 3 4
Status
Completed
Sponsor
AIIMS PATNA
Enrollment
108
Locations
1
Primary Endpoint
To determine the efficacy of High Flow Nasal Oxygenation in preventing reintubation within 48 hours of planned extubation by comparing the 1st, 6th, 12th, 24th, 48th hours ABG parameters and respiratory parameters with the NRM which may indcicate the need for re intubation.

Overview

Brief Summary

After extubation we are currently using conventional oxygen delivery devices like NRM  and sometimes other devices like nasal canula, face mask, venturi mas. When compared with other conventional oxygen delivery devicesafter extubation, high flow nasal oxygen provides physiological advantages since it can provide 100% FiO2 and 60L/min flow. Current data, mainly observational, show that HFNO could be used particularly for the management of hypoxemic ARF, notably in the more severe form. HFNO appears to be effective in patients experiencing high risk of respiratory failure after extubation compared with low-flow oxygen. As of yet, very few high-quality studies have been published evaluating these indications, so recommendations regarding clinical applications of HFNC remain tentative. This study is done to determine the efficacy  of High Flow Nasal Oxygenation in preventing reintubation within 48 hours of planned extubation.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
19.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age more than 18 years and less than 75 years BMI less than 30 kg/m2 Minimum 12 hours and maximum 7days of intubation period.

Exclusion Criteria

  • Tracheostomised patients Pregnant patient Patients with congestive heart disease Re intubated patients.

Outcomes

Primary Outcomes

To determine the efficacy of High Flow Nasal Oxygenation in preventing reintubation within 48 hours of planned extubation by comparing the 1st, 6th, 12th, 24th, 48th hours ABG parameters and respiratory parameters with the NRM which may indcicate the need for re intubation.

Time Frame: At 1st, 6th, 12th, 24th, 48th hours ABG parameters and respiratory parameters are recorded to look for any respiratory failure and rates of re intubation in

Secondary Outcomes

  • The respiartory failure within 48 hours of extubation measures via ABG & Respiratory parameters(1st, 6th, 12th, 24th, 48th hours ABG parameters & respiratory parameters are measures to assess for respiratory failure.)

Investigators

Sponsor
AIIMS PATNA
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Rasha Saleem

Aiims Patna

Study Sites (1)

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