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

August 26, 2021 updated by: Miguel Filipe Martins de Matos Navarro Guia, Hospital General Universitario Morales Meseguer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Murcia, Spain
        • Recruiting
        • Hospital General Universitario Morales Meseguer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NIV
Patients on Bilevel NIV
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
Other: 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
CPAP
Patients on CPAP
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour after initation of CPAP or NIV
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
1 - 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Morales Meseguer

Investigators

  • Principal Investigator: Miguel Guia, Hospital General Universitario Morales Meseguer
  • Study Director: Antonio Esquinas, Hospital General Universitario Morales Meseguer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Anticipated)

November 15, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-04-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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