NIV in Covid-19 Respiratory Failure

COVID-19 Pneumonia Clinical Trial

Official title:

Non-invasive Ventilation in Covid-19 Respiratory Failure - Predicting Success: A Retrospective Observational Study to Determine Predictive Factors in the Success or Failure of Non-invasive Ventilation.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05020691
• Other study ID #: 298787
• Status: Terminated
• Start date: August 18, 2021
• Est. completion date: November 3, 2021

Study information

• Verified date: November 2023
• Source: National Heatlh Service Ayrshire and Arran
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Respiratory Insufficiency

Locations

Country	Name	City	State
United Kingdom	University Hospital Crosshouse	Kilmarnock

Sponsors (1)

Lead Sponsor	Collaborator
National Heatlh Service Ayrshire and Arran

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Duan J, Han X, Bai L, Zhou L, Huang S. Assessment of heart rate, acidosis, consciousness, oxygenation, and respiratory rate to predict noninvasive ventilation failure in hypoxemic patients. Intensive Care Med. 2017 Feb;43(2):192-199. doi: 10.1007/s00134-016-4601-3. Epub 2016 Nov 3. — View Citation

Outcome

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