High flow oxygen therapy versus non-invasive ventilation for prevention of the need for repeat use of invasive mechanical ventilation in patients with increased blood carbon dioxide levels at the time of removal of endotracheal tube - a randomised controlled trial.

Phase 3

• Conditions: Health Condition 1: J962- Acute and chronic respiratory failure

• Registration Number: CTRI/2023/09/057425
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adults with hypercapnia at the time of extubation

Exclusion Criteria

1. Patients less than 18 years of age

2. Pregnant and breast-feeding women

3. Patients with do-not-resuscitate orders

4. Tracheostomised patients

5. Patients who underwent unplanned extubation (accidental extubation or self-extubation)

6. Patients with any contraindication for NIV (like orofacial/cranial trauma or surgery, orofacial malformation, excessive amount of secretions, weak cough and recent esophageal or gastric anastomosis, active emesis)

7. Patients receiving domiciliary non-invasive ventilation prior to hospitalisation

8. Refusal to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the reintubation rates within 72 hours after extubation between the two study groups. <br/ ><br>2. To compare the treatment failure rates between the two study groups.Timepoint: 1.To compare the reintubation rates within 72 hours after extubation between the two study groups. <br/ ><br>2. To compare the treatment failure rates between the two study groups.

Secondary Outcome Measures

Name	Time	Method
1.Respiratory rate at hour 1, hour 6, hour 24, hour 48 & hour 72 <br/ ><br>2.PH, paCO2, PF ratio at hour 1, hour 6, hour 24, hour 48 & hour 72 <br/ ><br>3.Reintubation rates from extubation to day 28 <br/ ><br>4.Days free of any ventilatory support from extubation to day 28 <br/ ><br>5.Treatment intolerance rates <br/ ><br>6.Nasofacial skin breakdown score (H1, 6, 24, 48, 72) <br/ ><br>7.Patient comfort score using VAS (H1, 6, 24, 48, 72) <br/ ><br>8.BORG dyspnea score (H1, 6, 24, 48, 72) <br/ ><br>9.Length of hospital and ICU stay <br/ ><br>10.ICU and in hospital mortality ratesTimepoint: Hours 1, 6, 24, 48, 72