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

NCT ID: NCT04342104

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure Covid-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NIV

Patients on Bilevel NIV

Monitoring for aggravation

Intervention Type OTHER

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

Intervention Type OTHER

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

Monitoring for aggravation

Intervention Type OTHER

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

Intervention Type OTHER

Apply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital General Universitario Morales Meseguer

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Miguel Filipe Martins de Matos Navarro Guia

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Miguel Guia

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Morales Meseguer

Antonio Esquinas

Role: STUDY_DIRECTOR

Hospital General Universitario Morales Meseguer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Miguel Guia

Role: CONTACT

00351915774975

Antonio Esquinas

Role: CONTACT

0034609321966

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Antonio Esquinas

Role: primary

0034609321966

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08-04-2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Inspiratory Effort in COVID-19
NCT04666246 RECRUITING
ARDS Caused by COVID-19
NCT04368975 UNKNOWN