Respiratory FailureNCT04342104
NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure
An observational study of Respiratory Failure and Covid-19, run by Hospital General Universitario Morales Meseguer at 1 site in Spain.
Trial summary
Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure. Propose adaptations to HACOR score based on the "state of art" of COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Covid-19
- What is being tested?
- Monitoring for aggravation and Evaluate HACOR score effectivity in this patients
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2020to 15 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 acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision
Who may be able to join
- Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision
Who cannot join
- Patients with imediate indication to invasive mechanical ventilation
- Patients with any formal contraindication to noninvasive respiratory support
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia
Antonio Esquinas, 0034609321966, antmesquinas@gmail.com
About this study
Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.
Propose adaptations to HACOR score based on the "state of art" of COVID-19
Read the detailed description
Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.
Propose adaptations to HACOR score based on the "state of art" of COVID-19
- this adaptations may include radiologic aggravation and monitoring of CRF, ferritin, LDH, d-dimers, NT-proBNP, troponin I, GOT, GPT, blood count
- Conditions
- Respiratory Failure, Covid-19
- Being tested
- Monitoring for aggravation, Evaluate HACOR score effectivity in this patients
- Keywords
- noninvasive ventilation, CPAP, Covid-19, Respiratory failure, HACOR score
- Medical subject headings
- Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring for aggravationOther
Monitor patients on CPAP or NIV and analyzing possible variables that may predict failure, namely:
- lymphopenia
- thrombocytopenia
- CRP
- ferritin
- LDH
- troponin I
- NT-ProBNP
- Liver enzymes
- D-dimers
- radiologic aggravation " 1 day and 1 week after starting NIV or CPAP
Evaluate HACOR score effectivity in this patientsOther
Apply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure
| Study group | Role | What they receive |
|---|---|---|
| NIV | Patients on Bilevel NIV Receives: Other: Monitoring for aggravation; Other: Evaluate HACOR score effectivity in this patients | |
| CPAP | Patients on CPAP Receives: Other: Monitoring for aggravation; Other: Evaluate HACOR score effectivity in this patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
HACOR score efficacy
Analyze if HACOR score is effective in predicting nonivasive ventilation failure in COVID-19 associated respiratory failure
Measured: 1 hour after initation of CPAP or NIV
HACOR score addaptation
Analyze the role of possible variables to be added to HACOR score in order to improve efficay in COVID-19 patients
Measured: 1 - 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Nov 2020
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Morales Meseguer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Filipe Martins de Matos Navarro Guia, Hospital General Universitario Morales Meseguer
- Investigators
- Miguel Guia, Principal investigator, Hospital General Universitario Morales MeseguerAntonio Esquinas, Study director, Hospital General Universitario Morales Meseguer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342104
- Sponsor's protocol ID
- 08-04-2020
- Status last verified
- Aug 2021
- First submitted
- 8 Apr 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure
- ClinicalTrials.gov ID
- NCT04342104
- Acronym / sponsor ID
- 08-04-2020
- Conditions
- Respiratory Failure, Covid-19
- Keywords
- noninvasive ventilation, CPAP, Covid-19, Respiratory failure, HACOR score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario Morales MeseguerUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 10 Apr 2020 (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.
Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.
Propose adaptations to HACOR score based on the "state of art" of COVID-19
Detailed description
Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.
Propose adaptations to HACOR score based on the "state of art" of COVID-19
- this adaptations may include radiologic aggravation and monitoring of CRF, ferritin, LDH, d-dimers, NT-proBNP, troponin I, GOT, GPT, blood count
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV | – | Other: Monitoring for aggravation, Other: Evaluate HACOR score effectivity in this patientsPatients on Bilevel NIV |
| CPAP | – | Other: Monitoring for aggravation, Other: Evaluate HACOR score effectivity in this patientsPatients on CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision
Key inclusion criteria (1 listed)
- Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision
Key exclusion criteria (2 listed)
- Patients with imediate indication to invasive mechanical ventilation
- Patients with any formal contraindication to noninvasive respiratory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring for aggravationMonitor patients on CPAP or NIV and analyzing possible variables that may predict failure, namely: * lymphopenia * thrombocytopenia * CRP * ferritin * LDH * troponin I * NT-ProBNP * Liver enzymes * D-dimers * radiologic aggravation " 1 day and 1 week after starting NIV or CPAP | Other | CPAP, NIV |
| Evaluate HACOR score effectivity in this patientsApply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure | Other | CPAP, NIV |
Primary outcome
HACOR score efficacy
Time frame: 1 hour after initation of CPAP or NIV
Analyze if HACOR score is effective in predicting nonivasive ventilation failure in COVID-19 associated respiratory failure
HACOR score addaptation
Time frame: 1 - 2 weeks
Analyze the role of possible variables to be added to HACOR score in order to improve efficay in COVID-19 patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Miguel Guia principal investigator
Hospital General Universitario Morales Meseguer
Antonio Esquinas study director
Hospital General Universitario Morales Meseguer
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 Respiratory Failure and Covid-19, run by Hospital General Universitario Morales Meseguer at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Guia (00351915774975, miguelguia7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HACOR score efficacy (time frame: 1 hour after initation of CPAP or NIV). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2021.