Predictive Factors for Failure of Non-invasive Support Ventilation in Patients With COVID-19: A Retrospective Study.

NCT ID: NCT05579080

Last Updated: 2023-04-07

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

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Recruitment Status

COMPLETED

Total Enrollment

1319 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-04-06

Brief Summary

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During the progression of COVID-19, some patients may require noninvasive ventilation (NIV) or high-flow nasal catheter (CNAF) oxygen therapy. The objective of the study is describe, retrospectively, possible predictor variables related to the use of NIV and CNAF, in order to associate them with their failure and consequent orotracheal intubation, through a retrospective analysis of a tertiary hospital in Rio de Janeiro. The primary and second outcomes are incidence of orotracheal intubation; time for OIT, length of stay in the ICU and hospital, and in-hospital mortality. The preliminary results shows that the absence of heart disease and dementia, as well as the acute onset of symptoms (less than or equal to 10 days) and age (between 40 and 79 years) showed a statistically significant trend.

Detailed Description

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Introduction: COVID-19 is an infectious disease caused by SARS-CoV2 (severe acute respiratory syndrome by the novo coronavirus). During the progression of COVID-19 infection, some patients may require noninvasive ventilation (NIV) or high-flow nasal catheter oxygen therapy (HFNC). However, its use has proved controversial in this population. Objective: To describe, retrospectively, possible predictor variables related to the use of NIV and HFNC, in order to associate them with their failure and consequent orotracheal intubation. Materials and Methods: observational, retrospective study, according to STROBE model, from the analysis of medical records, between March 2020 and July 2021. Study approved by a co-substantiated committee of D'or research and teaching institute (CAAE: 52534221.5.0000.5249). Inclusion criteria: over 18 years of age, diagnosis of positive COVID-19, hospitalized in the ICU of a tertiary Hospital located in Rio de Janeiro, admitted between March 2020 and July 2021. Exclusion criteria: hospital stay time of less than 3 days; patients who evolved to IOT in less than 48 hours; patients whose therapy (NIV, CNAF or NIV + CNAF) lasted less than 48 hours; patients whose medical records do not have the variables for the study. Primary outcome: incidence of orotracheal intubation. Secondary outcomes: time for orotracheal intubation, length of stay in the ICU and hospital and in-hospital mortality. Statistical analysis: There was no sample calculation due to the exploratory, descriptive and retrospective nature of this study. The Mann-Whitney U test will be applied to assess differences in icu length of stay. Survival time as well as hospital length of stay until the event will be analyzed with Kaplan-Meier estimates; the log-rank test will be used for group comparison. The p-\< 0.05 will be considered statistically significant. Preliminary results: 82.6% of the medical records completed phase 1 of data collection. Of these, 64.4% used CNAF, NIV or both. 20% of the medical records passed through phase 1 completed for phase 2 collection, with characterization of the population. The absence of heart disease and dementia, as well as the acute onset of symptoms (less than or equal to 10 days) and age (between 40 and 79 years) showed a statistically significant trend.

Conditions

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COVID-19 Pneumonia COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NIV group

group that performed only non-invasive ventilation

noninvasive ventilation

Intervention Type DEVICE

The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.

HFNC group

group that performed only oxygen therapy by high flow nasal cannula

noninvasive ventilation

Intervention Type DEVICE

The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.

NIV and HFNC group

group that used non-invasive ventilation and oxygen therapy by high flow nasal cannula

noninvasive ventilation

Intervention Type DEVICE

The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.

conventional oxygen therapy group

group that used only conventional oxygen therapy low-flow oxygen therapy.

noninvasive ventilation

Intervention Type DEVICE

The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.

Interventions

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noninvasive ventilation

The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.

Intervention Type DEVICE

Other Intervention Names

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conventional oxygen therapy high flow nasal cannula

Eligibility Criteria

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Inclusion Criteria

* Adult patients, 18 years of age and older,
* admitted to the ICU with COVID-19 confirmed by positive reverse transcriptase reaction followed by the polymerase chain reaction or chest CT suggestive of pneumonia caused by COVID-19
* admitted between March 2020 and July 2021.

Exclusion Criteria

* Estimated length of hospital stay less than 3 days;

* Patients who progressed to OTI in less than 48 hours of hospital stay;
* Patients whose use of NIV and/or HFNC lasted less than 48 hours;
* Patients whose medical records lack predictive and outcome variables.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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JOSE ROBERTO LAPA E SILVA

Jose Roberto Lapa e Silva

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro Silva

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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Universidade Federal do Rio de Janeiro

Rio de Janeiro, , Brazil

Site Status

Barra D'or Hospital

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

References

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da Cruz AP, Martins G, Martins CM, Marques V, Christovam S, Battaglini D, Robba C, Pelosi P, Rocco PRM, Cruz FF, Dos Santos Samary C, Silva PL. Comparison between high-flow nasal oxygen (HFNO) alternated with non-invasive ventilation (NIV) and HFNO and NIV alone in patients with COVID-19: a retrospective cohort study. Eur J Med Res. 2024 Apr 22;29(1):248. doi: 10.1186/s40001-024-01826-3.

Reference Type DERIVED
PMID: 38649940 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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52534221.5.0000.5249

Identifier Type: -

Identifier Source: org_study_id

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