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Comparison of a helmet interface for non invasive ventilation versus high flow nasal oxygen therapy in management of Corona virus patients.

High flow nasal oxygen (NO) versus helmet interface non invasive ventilation in COVID 19 patients. The NO-Hel Study. - NO-Hel Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029711
Enrollment
56
Registered
2020-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Use of Helmet interfaced of Non invasive ventilation.: After randomization, all patients with diagnosed corona virus infection fulfilling the inclusion criteria shall be given respirato

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with corona virus infection presenting with all of the following. a. A ratio of partial pressure of oxygen (PaO2) to (FiO2) below 300. b. PaCO2 less than 45 mmHg as well as c. Respiratory rate greater than 25/ minute

Exclusion criteria

Exclusion criteria: 1. cardiogenic pulmonary edema, 2. severe neutropenia, 3. hemodynamic instability, 4. Use of vasopressors, 5. Glasgow Coma Scale score of 12 points or less 6. loss of protective gag reflex 7. urgent need for intubation 8. presence of metabolic acidosis with arterial blood pH 9. History of any underlying chronic lung disease.

Design outcomes

Secondary

MeasureTime frame
To compare time to intubation ie hours from time of initiation of intervention until intubation.Timepoint: From time of initiation of intervention to time of intubation.;To assess intubation-free daysTimepoint: From the time of randomization to a maximum of 28 days after randomization.;To compare rates of mortality or discharge from hospital.Timepoint: At time of mortality or discharge from hospital, upto a maximum of 28 days after randomization.;To compare PaO2/FiO2 ratio, PaCO2 and PH changes after 24 hrs, and 48 hrs of therapyTimepoint: 24 hours and 48 hours after initiation of either therapy.

Primary

MeasureTime frame
To compare rate of intubations in patients getting high flow nasal oxygen (HFNO) versus helmet interface NIV for management of Covid patients.Timepoint: Intubation at any time during hospital stay up to a maximum of 28 days shall be assessed.

Countries

India

Contacts

Public ContactNISHANT SAHAY

AIIMS Patna

nishantsahay@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026