COVID-19COVID-19NCT05663528
ANALYSIS OF CLINICAL AND LABORATORY VARIABLES WITH PREDICTION CAPABILITY FOR INDICATION OF INVASIVE MECHANICAL VENTILATION IN PATIENTS WITH COVID-19
An observational study of COVID-19, run by Universidade Federal do Rio de Janeiro at 3 sites in Brazil.
Trial summary
This observational and retrospective study will follow the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The aim is to verify and analyze the clinical and laboratory variables with prediction capability for indication of invasive ventilatory support in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- orotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 3 sitesBrazil
- Study dates
- 1 Mar 2023to 26 Jan 2024
- 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: Patients with confirmation of covid-19 and with length of stay in the intensive care unit greater than 48 hours will be selected for the intubated and non-intubated groups. For the intubated group, patients who underwent endotracheal intubation after 48 hours of admission to the intensive care unit will be selected. For the non-intubated group, those patients who were not intubated during their stay in the intensive care unit will be selected.
Who may be able to join
- The inclusion criteria will be individuals with confirmed diagnosis of COVID-19 by RT-PCR (reverse- transcriptase polymerase chain reaction), with minimum length of stay of 24 hours in the ICU and, patients who sign the free and clarified consent.
Who cannot join
- The exclusion criteria for participation in the study will be as follows: (1) patients under the age of 18; (2) patients with a negative laboratory test for COVID-19; (3) patients in need of emergency intubation; (4) patients who underwent previous endotracheal intubation at the same hospitalization.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Pedro Ernesto University Hospital
Rio de Janeiro, 20551-030
National Institute of Infectology Evandro Chagas
Rio de Janeiro, 21040-360
Clementino Fraga Filho University Hospital
Rio de Janeiro, 21941-617
About this study
This observational and retrospective study will follow the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The aim is to verify and analyze the clinical and laboratory variables with prediction capability for indication of invasive ventilatory support in patients with COVID-19. The present study will be carried out in specific care units for patients with suspected or confirmed COVID-19. Individuals with suspected or clinical diagnosis of COVID-19, with a minimum hospital stay of 24 hours and submitted to oxygen therapy or non-invasive ventilation will be selected. Clinical and laboratory variables will be collected from the moment of admission and every 12 hours until the third day of hospitalization. The primary outcome will be rate of endotracheal intubation, while secondary outocomes will be lenght of stay in intensive care unit, and hospital, as well as mortality rate.
Read the detailed description
Clinical and laboratory data will be collected from medical records from the period of the COVID-19 pandemic (February 2020 to June 2021)
- Conditions
- COVID-19
- Being tested
- orotracheal intubation
- Keywords
- mechanical ventilation, Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orotracheal intubationProcedure or surgery
Also called invasive mechanical ventilation
Clinical and laboratory data will be collected from patients who are intubated after 48 hours of admission to the intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| orotracheal intubation group | Composed of Patients who were intubated after 48 hours of admission to the intensive care unit Receives: Procedure: orotracheal intubation | |
| non-intubated group | Composed of patients who were not intubated during their stay in the intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify clinical and laboratory variables that may be associated with the need of endotracheal intubation in the first 72 hours of admission to the intensive care unit.
Vital signs will be collected through the cardiac monitor and clinical evaluation from the moment of admission until the third day of hospitalization, every twelve hours and full blood count and biochemistry data will be collected from patients at admission until the third day of hospitalization in the intensive care unit
Measured: 3 days
Secondary outcomes (5)
time to endotracheal intubation
It will be collected from the date of intensive care unit admission until the date of endotracheal intubation
Measured: 28 days
length of stay in the ICU
It will be collected from the date of intensive care unit admission until the outcome of discharge from the intensive care unit or death.
Measured: 6 months
length of hospital
It will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death.
Measured: 12 months
mechanical ventilation days
It will be collected from the date of intubation in the intensive care unit until the date of extubation or up to 48 hours off mechanical ventilation in cases of tracheostomized patients and/or until the outcome of death
Measured: 6 months
hospital mortality
Mortality will be collected during the period of hospitalization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Mar 2023
- Primary completion31 Oct 2023
- Study completion26 Jan 2024
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-19Studies 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
- 350 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663528
- Sponsor's protocol ID
- 100685
- Acronym
- COVID-19
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maia G, Martins CM, Marques V, Christovam S, Prado I, Moraes B, Rezoagli E, Foti G, Zambelli V, Cereda M, Berra L, Rocco PRM, Cruz MR, Samary CDS, Guimaraes FS, Silva PL. Derivation and external validation of predictive models for invasive mechanical ventilation in intensive care unit patients with COVID-19. Ann Intensive Care. 2024 Aug 21;14(1):129. doi: 10.1186/s13613-024-01357-4.
PubMed 39167241
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALYSIS OF CLINICAL AND LABORATORY VARIABLES WITH PREDICTION CAPABILITY FOR INDICATION OF INVASIVE MECHANICAL VENTILATION IN PATIENTS WITH COVID-19
- ClinicalTrials.gov ID
- NCT05663528
- Acronym / sponsor ID
- COVID-19 / 100685
- Conditions
- COVID-19
- Keywords
- mechanical ventilation, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 23 Dec 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.
This observational and retrospective study will follow the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The aim is to verify and analyze the clinical and laboratory variables with prediction capability for indication of invasive ventilatory support in patients with COVID-19. The present study will be carried out in specific care units for patients with suspected or confirmed COVID-19. Individuals with suspected or clinical diagnosis of COVID-19, with a minimum hospital stay of 24 hours and submitted to oxygen therapy or non-invasive ventilation will be selected. Clinical and laboratory variables will be collected from the moment of admission and every 12 hours until the third day of hospitalization. The primary outcome will be rate of endotracheal intubation, while secondary outocomes will be lenght of stay in intensive care unit, and hospital, as well as mortality rate.
Detailed description
Clinical and laboratory data will be collected from medical records from the period of the COVID-19 pandemic (February 2020 to June 2021)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orotracheal intubation group | – | Procedure: orotracheal intubationComposed of Patients who were intubated after 48 hours of admission to the intensive care unit |
| non-intubated group | – | –Composed of patients who were not intubated during their stay in the intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmation of covid-19 and with length of stay in the intensive care unit greater than 48 hours will be selected for the intubated and non-intubated groups. For the intubated group, patients who underwent endotracheal intubation after 48 hours of admission to the intensive care unit will be selected. For the non-intubated group, those patients who were not intubated during their stay in the intensive care unit will be selected.
Key inclusion criteria (1 listed)
- The inclusion criteria will be individuals with confirmed diagnosis of COVID-19 by RT-PCR (reverse- transcriptase polymerase chain reaction), with minimum length of stay of 24 hours in the ICU and, patients who sign the free and clarified consent.
Key exclusion criteria (1 listed)
- The exclusion criteria for participation in the study will be as follows: (1) patients under the age of 18; (2) patients with a negative laboratory test for COVID-19; (3) patients in need of emergency intubation; (4) patients who underwent previous endotracheal intubation at the same hospitalization.
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 |
|---|---|---|
| orotracheal intubationAlso: invasive mechanical ventilationClinical and laboratory data will be collected from patients who are intubated after 48 hours of admission to the intensive care unit | Procedure or surgery | orotracheal intubation group |
Primary outcome
Identify clinical and laboratory variables that may be associated with the need of endotracheal intubation in the first 72 hours of admission to the intensive care unit.
Time frame: 3 days
Vital signs will be collected through the cardiac monitor and clinical evaluation from the moment of admission until the third day of hospitalization, every twelve hours and full blood count and biochemistry data will be collected from patients at admission until the third day of hospitalization in the intensive care unit
5 secondary outcomes
time to endotracheal intubation
Time frame: 28 days
length of stay in the ICU
Time frame: 6 months
length of hospital
Time frame: 12 months
mechanical ventilation days
Time frame: 6 months
hospital mortality
Time frame: 12 months
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 30 Jan 2024.
- Derived from this study: PubMed 39167241Maia G, Martins CM, Marques V, Christovam S, Prado I, Moraes B, Rezoagli E, Foti G, Zambelli V, Cereda M, Berra L, Rocco PRM, Cruz MR, Samary CDS, Guimaraes FS, Silva PL. Derivation and external validation of predictive models for invasive mechanical ventilation in intensive care unit patients with COVID-19. Ann Intensive Care. 2024 Aug 21;14(1):129. doi: 10.1186/s13613-024-01357-4.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
3 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, run by Universidade Federal do Rio de Janeiro at 3 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 1 inclusion and 1 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Identify clinical and laboratory variables that may be associated with the need of endotracheal intubation in the first 72 hours of admission to the intensive care unit. (time frame: 3 days). 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 NCT05663528, 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 30 Jan 2024.