COVID-19 PneumoniaNCT05020691
NIV in Covid-19 Respiratory Failure
An observational study of COVID-19 Pneumonia, run by National Heatlh Service Ayrshire and Arran at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2021to 3 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed Covid-19 respiratory failure treated with facemask CPAP in a district general hospital
Who may be able to join
- 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
Who cannot join
- Patients with immediate indication for invasive ventilation
- Patients whose primary diagnosis was not Covid-19 respiratory failure, but received NIV in that time period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Crosshouse
Kilmarnock, KA2 0BE
About this study
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.
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia
- Keywords
- Covid-19, HACOR, Non-Invasive Ventilation, CPAP
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Escalation to Invasive Ventilation
Number of patients who deteriorated after NIV commenced, requiring escalation to invasive ventilation
Measured: Up to 6 months
Death Due to Respiratory Failure
Number of patients who deteriorated after NIV commenced, resulting in death due to respiratory failure
Measured: Up to 6 months
Clinical Improvement
Number of patients who improved after NIV commenced, resulting in liberation from NIV (without requiring invasive ventilation)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start18 Aug 2021
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Why it stopped: Availability of research team limited by clinical workload (COVID-19)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heatlh Service Ayrshire and Arran
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jamie Hooker, National Heatlh Service Ayrshire and Arran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020691
- Sponsor's protocol ID
- 298787
- Status last verified
- Nov 2023
- First submitted
- 17 Aug 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27812731
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05020691
- Acronym / sponsor ID
- 298787
- Conditions
- COVID-19 Pneumonia
- Keywords
- Covid-19, HACOR, Non-Invasive Ventilation, CPAP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Availability of research team limited by clinical workload (COVID-19)
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Heatlh Service Ayrshire and ArranOther government
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed Covid-19 respiratory failure treated with facemask CPAP in a district general hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with immediate indication for invasive ventilation
- Patients whose primary diagnosis was not Covid-19 respiratory failure, but received NIV in that time period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Escalation to Invasive Ventilation
Time frame: Up to 6 months
Number of patients who deteriorated after NIV commenced, requiring escalation to invasive ventilation
Death Due to Respiratory Failure
Time frame: Up to 6 months
Number of patients who deteriorated after NIV commenced, resulting in death due to respiratory failure
Clinical Improvement
Time frame: Up to 6 months
Number of patients who improved after NIV commenced, resulting in liberation from NIV (without requiring invasive ventilation)
Results and safety
The study was stopped early (reason given: Availability of research team limited by clinical workload (COVID-19)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 27812731Duan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by National Heatlh Service Ayrshire and Arran at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Availability of research team limited by clinical workload (COVID-19)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Escalation to Invasive Ventilation (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.