NIV in Covid-19 Respiratory Failure

Terminated

• Conditions: COVID-19 Pneumonia

• Registration Number: NCT05020691
• Lead Sponsor: National Heatlh Service Ayrshire and Arran

Brief Summary

A retrospective, single centre observational study to validate use of the HACOR score (Duan et al, 2017) in determining efficacy of non-invasive ventilation in Covid-19 respiratory failure.

Detailed Description

The investigators will retrospectively analyse medical records of patients with confirmed Covid-19 respiratory failure who received continuous positive airway pressure (CPAP) via facemask, as per clinician decision, in the High Dependency Unit (HDU) or Intensive Care Unit (ICU) of University Hospital Crosshouse between 1st March 2020 and 30th April 2021. By collecting baseline demographics and physiological data (including APACHE II and clinical frailty score) and calculating the HACOR score at initiation of CPAP, then at 1hr, 6hrs, 12hrs, 24hrs and 48hrs after initiating CPAP the investigators aim to validate use of the HACOR score in determining efficacy of NIV in Covid-19 respiratory failure. The investigators will also collect other variables (CRP and lymphocytes, lactate, mean arterial pressure, temperature) to determine if these factors have utility in predicting efficacy of NIV in Covid-19 respiratory failure.

Study Timeline

• Study First Submitted: 2021-08-17
• Study Start: 2021-08-18
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-25
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Confirmed Covid-19 respiratory failure
2. NIV treatment instituted as per clinician decision
3. Admitted to HDU or ICU between 1/3/20 and 30/4/21

Exclusion Criteria

1. Patients with immediate indication for invasive ventilation
2. Patients whose primary diagnosis was not Covid-19 respiratory failure, but received NIV in that time period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Improvement	Up to 6 months	Number of patients who improved after NIV commenced, resulting in liberation from NIV (without requiring invasive ventilation)
Escalation to Invasive Ventilation	Up to 6 months	Number of patients who deteriorated after NIV commenced, requiring escalation to invasive ventilation
Death Due to Respiratory Failure	Up to 6 months	Number of patients who deteriorated after NIV commenced, resulting in death due to respiratory failure

Trial Locations

Locations (1)

University Hospital Crosshouse; 🇬🇧 Kilmarnock, United Kingdom