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Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia

NCT05094661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2022-11-08

No results posted yet for this study

Summary

The main objective of the current study is to search predictors of non-invasive respiratory support failure, like high -flow oxygen system (HFO) and pressure systems, Bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP), in patients with acute hypoxemia produced by COVID-19 pneumonia.

In the first phase, we will do a retrospective review of the intermediate respiratory care unit activity from March to May 2020 in the target population. In the second phase development an interventional study. At admission all patients will be treated with HFS monitoring clinical variables like respiratory frequency, oxygen saturation, gasometer results and oxygen inspiration fraction. In case of HFO failure, the patients will be randomized to treatment with CPAP or BIPAP. The same clinical variables will be monitoring to analysis their prediction capacity of failure therapy, defined as mortality or need to intubation. The results will be adjusted comorbidity grade, age and initial severity pneumonia. Secondary objectives of study are 90 days mortality, functional recovery at 90 days and to realise a cost-effectiveness valuation of non-invasive respiratory supports in this disease.

Conditions

  • Noninvasive Ventilation
  • Covid19
  • Distress; Respiratory Syndrome, Adult

Interventions

PROCEDURE

BiPAP

The patient recives respiratory support with bilevel positive airway pressure system until treatment improves or fails (needs intubation/dies).

PROCEDURE

CPAP

The patient recives respiratory support with continuous positive airway pressure system until treatment improves or fails (needs intubation/dies).

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Irene IA Aldás Criado · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2022-11-07
Completion
2022-11-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05094661 on ClinicalTrials.gov