A study to see if a new breathing device called the indigenous HFNC to give oxygen and humidification help people with acute breathing problems more effectively than the standard HFNC device
Phase 3
- Conditions
- Health Condition 1: J960- Acute respiratory failure
- Registration Number
- CTRI/2023/08/056098
- Lead Sponsor
- Amrita Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. The eligibility criteria for this study would be (1) Inborn babies with respiratory distress (clinical / laboratory)
2. RSS Mild to moderate
3. SPO2 <= 94% on low-flow oxygen therapy or needs a high-flow device
4. In preterm 88-92% ( < 28 weeks)
5. Signs of increased work of breathing on low oxygen
Exclusion Criteria
•RSS scoring: Severe respiratory distress
•Underlying hemodynamic instability
• Congenital heart disease which is critical
•midfacial anomalies prohibiting the use of nasal cannula and
• those requiring immediate intubation and ventilation because of apnea, respiratory failure, or profound hypoxemia
•Do not Resuscitate (DNR)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in oxygentation via SPO2, PaO2Timepoint: Baseline, 2hr, 8 hr, 12 hr, 24 hr, 48, hr, 90 days
- Secondary Outcome Measures
Name Time Method To determine the changes in the FiO2 requirement, improvement in PCO2 levels, hospital lengths of stay, 90-d mortality, & adverse effects after the HFNC treatment when compared to standard HFNC deviceTimepoint: 90-d mortality