NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure
1 other identifier
observational
100
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2021
CompletedAugust 30, 2021
August 1, 2021
8 months
April 8, 2020
August 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HACOR score efficacy
Analyze if HACOR score is effective in predicting nonivasive ventilation failure in COVID-19 associated respiratory failure
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
1 - 2 weeks
Study Arms (2)
NIV
Patients on Bilevel NIV
CPAP
Patients on CPAP
Interventions
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
Apply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure
Eligibility Criteria
Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision
You may qualify if:
- Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision
You may not qualify if:
- Patients with imediate indication to invasive mechanical ventilation
- Patients with any formal contraindication to noninvasive respiratory support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Universitario Morales Meseguer
Murcia, Spain
Biospecimen
Blood sample for biochemistry and blood count
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel Guia
Hospital General Universitario Morales Meseguer
- STUDY DIRECTOR
Antonio Esquinas
Hospital General Universitario Morales Meseguer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 10, 2020
Study Start
April 1, 2020
Primary Completion
November 30, 2020
Study Completion
November 15, 2021
Last Updated
August 30, 2021
Record last verified: 2021-08