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A multicentre observational study to look into the practise of using non invasive ventilation in COVID-19 patients requiring ICU admission for respiratory support and their outcome in terms of their failure rate as well as exploiting the HACOR scale to predict NiV failure.

A multicentre observational study on the practise of non invasive ventilation in COVID-19 patients with De novo acute hypoxemic respiratory failure and utilising HACOR scale to predict failure - MONICA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031409
Enrollment
500
Registered
2021-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

None listed

Sponsors

DR Saurav Sutradhar
Lead Sponsor
Dr Devi Prasad Dash
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All the patients 18 years & above of age, suspected or tested positive for SARS-COV2 (RtPCR/RAT) being admitted to the Intensive care with de novo acute hypoxemic respiratory failure defined as recent onset respiratory failure as evidenced by a P/F ratio of less than equal to 300 mmHg, signs of respiratory distress along with the presence of pulmonary infiltrates on chest images, in the absence of chronic cardio-respiratory diseases, including extubation failure with hypoxemia and, in whom NiV was initiated and administered for at least 30 minutes. The underlying condition deemed to have caused DNAHRF and the reason for NiV initiation was adjudged by the treating Critical care physician and documented. ARDS will be diagnosed as per the BERLIN criteria.

Exclusion criteria

Exclusion criteria: All patients with history of chronic cardio-respiratory illness as well as those who are home O2/Niv user. Patients who have failed extubation as well as those refusing NiV due to intolerance or with do not intubate orders.

Design outcomes

Primary

MeasureTime frame
1. NiV failure rate 2. Patient Outcome in terms of death or discharge from ICU among patients with Early and Late groups of NiV failure. Timepoint: Patients parameters will be assessed at baseline before Non invasive ventilation (NiV) initiation, thereafter at 1 hour, 24 hours and at 48 hours post NiV usage. The patient will be followed for a maximum period of 28 days in the ICU.—

Secondary

MeasureTime frame
Utilasation of HACOR scale to predict NiV failureTimepoint: Patients bed side parameters will be assessed at baseline prior to NiV usage and thereafter at 1 hour, 24 hours and 48 hours of NiV initiation.—

Countries

India

Contacts

Public ContactSaurav Sutradhar

Kalinga Institute of Medical Sciences (KIMS)

drsauravindia@gmail.com8130241372

Outcome results

None listed

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