Clinical Efficacy of the Indigenously Developed Oxygen delivery device : A Pilot Study
- Registration Number
- CTRI/2024/02/062209
- Lead Sponsor
- Department of Science and Technology (DST)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy men and women aged between 20-50 years
2. Willing to give written, informed consent
3. Willing to comply with protocol requirements
4. Normal physical & systemic examination
5. Have normal hemogram and renal function test in the past 6 months
6. BMI 18 to 30
7. Non-smokers and no history of respiratory disease
1.Elderly, above 50 years
2.Known respiratory disease
3.Recent less than 3 months mechanical ventilation ICU, hospital admission
4.Anemia
5.History of Hemoglobinopathy, sickle cell disease, thalassemia
6 Positive pregnancy test, females
7.Significant cardiac or pulmonary disease
8.History of sleep apnea
9.Tobacco, drug or alcohol abuse
10.Difficult airway
11.Abnormal ekg, pulmonary function test, room air saturation
12.Intolerance to HFNC apparatus
13.Participation in Phase I study in previous 6 months or in Phase 2 or 3 studies in previous 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Agreement between measured and predicted arterial partial pressure of oxygen PaO2 for each FiO2 percentage changeTimepoint: At Baseline and after 20 minutes for all 4 sessions intervention sessions mentioned in study protocol
- Secondary Outcome Measures
Name Time Method Change in vital parameters (HR, BP, SpO2, RR) at the end of each session from baseline <br/ ><br>Timepoint: every 5 minutes from start of intervention till 1 hour after the end of intervention.;Proportion of patients experiencing adverse and serious adverse events.Timepoint: every 5 minutes from start of intervention till 1 hour after the end of intervention.