NCT05020691

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

August 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2021

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

August 17, 2021

Last Update Submit

November 7, 2023

Conditions

COVID-19 Pneumonia

Keywords

Covid-19HACORNon-Invasive VentilationCPAP

Outcome Measures

Primary Outcomes (3)

  • Escalation to Invasive Ventilation

    Number of patients who deteriorated after NIV commenced, requiring escalation to invasive ventilation

    Up to 6 months

  • Death Due to Respiratory Failure

    Number of patients who deteriorated after NIV commenced, resulting in death due to respiratory failure

    Up to 6 months

  • Clinical Improvement

    Number of patients who improved after NIV commenced, resulting in liberation from NIV (without requiring invasive ventilation)

    Up to 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with confirmed Covid-19 respiratory failure treated with facemask CPAP in a district general hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Crosshouse

Kilmarnock, KA2 0BE, United Kingdom

Location

Related 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.

    PMID: 27812731BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Clinical Fellow, Intensive Care

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 25, 2021

Study Start

August 18, 2021

Primary Completion

November 3, 2021

Study Completion

November 3, 2021

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)