COVID-19 PneumoniaNCT05579080
Predictive Factors for Failure of Non-invasive Support Ventilation in Patients With COVID-19: A Retrospective Study.
An observational study of COVID-19 Pneumonia and COVID-19, run by Universidade Federal do Rio de Janeiro at 2 sites in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, COVID-19
- What is being tested?
- noninvasive ventilation
- Type of treatment
- Medical device
- How many people
- 1,319 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Dec 2021to 6 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients, 18 years of age and older, admitted to the ICU with COVID-19 confirmed by positive RT-PCR or chest CT suggestive of pneumonia caused by COVID-19, admitted between March 2020 and July 2021, who progressed to respiratory failure, requiring some ventilatory support or supplemental oxygen therapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Universidade Federal do Rio de Janeiro
Rio de Janeiro, 21941902
Barra D'or Hospital
Rio de Janeiro
About this study
Official title: Predictive Factors for Failure of Non-invasive Ventilation and High-flow Oxygen Therapy in COVID-19 Patients: A Retrospective Observational Study.
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.
Read the detailed description
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
- COVID-19 Pneumonia, COVID-19
- Being tested
- noninvasive ventilation
- Keywords
- self-patient lung injury, outcome, COVID-19 infection, noninvasive ventilation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive ventilationDevice
Also called conventional oxygen therapy, high flow nasal cannula
The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| NIV group | group that performed only non-invasive ventilation Receives: Device: noninvasive ventilation | |
| HFNC group | group that performed only oxygen therapy by high flow nasal cannula Receives: Device: noninvasive ventilation | |
| NIV and HFNC group | group that used non-invasive ventilation and oxygen therapy by high flow nasal cannula Receives: Device: noninvasive ventilation | |
| conventional oxygen therapy group | group that used only conventional oxygen therapy low-flow oxygen therapy. Receives: Device: noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
orotracheal intubation
failure of noninvasive ventilatory therapy through the need for orotracheal intubation
Measured: during hospitalization
Secondary outcomes (3)
length of stay in the ICU
length of stay in the ICU
Measured: during hospitalization
length of stay in hospital
length of stay in hospital
Measured: during hospitalization
in-hospital mortality
in-hospital mortality
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Dec 2021
- Primary completion13 Sep 2022
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOSE ROBERTO LAPA E SILVA, Universidade Federal do Rio de Janeiro
- Investigators
- Pedro Silva, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579080
- Sponsor's protocol ID
- 52534221.5.0000.5249
- Status last verified
- Apr 2023
- First submitted
- 11 Oct 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38649940
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Failure of Non-invasive Ventilation and High-flow Oxygen Therapy in COVID-19 Patients: A Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT05579080
- Acronym / sponsor ID
- 52534221.5.0000.5249
- Conditions
- COVID-19 Pneumonia, COVID-19
- Keywords
- self-patient lung injury, outcome, COVID-19 infection, noninvasive ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,319 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NIV group | – | Device: noninvasive ventilationgroup that performed only non-invasive ventilation |
| HFNC group | – | Device: noninvasive ventilationgroup that performed only oxygen therapy by high flow nasal cannula |
| NIV and HFNC group | – | Device: noninvasive ventilationgroup that used non-invasive ventilation and oxygen therapy by high flow nasal cannula |
| conventional oxygen therapy group | – | Device: noninvasive ventilationgroup that used only conventional oxygen therapy low-flow oxygen therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients, 18 years of age and older, admitted to the ICU with COVID-19 confirmed by positive RT-PCR or chest CT suggestive of pneumonia caused by COVID-19, admitted between March 2020 and July 2021, who progressed to respiratory failure, requiring some ventilatory support or supplemental oxygen therapy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Estimated length of hospital stay less than 3 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noninvasive ventilationAlso: conventional oxygen therapy, high flow nasal cannulaThe medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed. | Device | HFNC group, NIV and HFNC group, NIV group, conventional oxygen therapy group |
Primary outcome
orotracheal intubation
Time frame: during hospitalization
failure of noninvasive ventilatory therapy through the need for orotracheal intubation
3 secondary outcomes
length of stay in the ICU
Time frame: during hospitalization
length of stay in hospital
Time frame: during hospitalization
in-hospital mortality
Time frame: during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 38649940da 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Silva principal investigator
Universidade Federal do Rio de Janeiro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and COVID-19, run by Universidade Federal do Rio de Janeiro at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orotracheal intubation (time frame: during hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05579080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.