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.

High flow nasal oxygen therapy versus non-invasive ventilation for prevention of reintubation in patients with hypercapnia at extubation– a randomised controlled trial (HYPERHOT - NIV TRIAL) - HYPERHOT-NIV TRIAL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057425

Enrollment

208

Registered

2023-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J962- Acute and chronic respiratory failure

Interventions

Intervention1: High flow nasal cannula: High flow oxygen therapy via high flow nasal cannula for a minimum of 6 hours to a maximum of 24 hours Control Intervention1: Non invasive ventilation: Non inva

Eligibility

Inclusion criteria

Inclusion criteria: Adults with hypercapnia at the time of extubation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1.To compare the reintubation rates within 72 hours after extubation between the two study groups. 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. 2. To compare the treatment failure rates between the two study groups.	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactMUNIZA BAI

AIIMS New Delhi

vijayhadda@yahoo.com9868883208

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026