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NCT04342104 Clinical Trial

NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure

Covid-19 Clinical Trial

Official title:
NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04342104
Other study ID # 08-04-2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date November 15, 2021

Study information
Verified date August 2021
Source Hospital General Universitario Morales Meseguer
Contact Miguel Guia
Phone 00351915774975
Email miguelguia7@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date November 15, 2021
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision Exclusion Criteria: - Patients with imediate indication to invasive mechanical ventilation - Patients with any formal contraindication to noninvasive respiratory support

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Monitoring for aggravation
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 patients
Apply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure

Locations
Country Name City State
Spain Hospital General Universitario Morales Meseguer Murcia

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Morales Meseguer

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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