Mechanical VentilationNCT04642703
Mortality in Patients With Severe COVID-19 Pneumonia Who Underwent Tracheostomy
An observational study of Mechanical Ventilation and Covid19, run by University of Chile at 1 site in Chile.
Trial summary
Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Covid19, Tracheostomy
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 3 Mar 2020to 30 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 patients with respiratory failure needing mechanical ventilation for 10 days or longer
Who may be able to join
- COVID-19 confirmed case
- Invasive mechanical ventilation by 10 days or longer
Who cannot join
- Childhood
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Intensive Care Unit, Hospital Clínico Universidad de Chile
Santiago
Carlos Romero, MD, +56229788264, mvenegash@hcuch.cl
Abraham Gajardo, MD, 56229789162, intermediomedico@hcuch.cl
About this study
Official title: Mortality in Patients With Severe SARS-CoV-2 Pneumonia Who Underwent Tracheostomy Due to Prolonged Mechanical Ventilation
Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. This study aims to compare in-hospital mortality in COVID-19 patients with and without tracheostomy due to prolonged IMV Methods: Cohort study of adult COVID-19 patients subjected to prolonged IMV. Since the first COVID-19 case (March 3, 2020) up to November 30, 2020, all adult critical patients supported with IMV by 10 days or more at the Hospital Clínico Universidad de Chile will be included in the cohort. Pregnant women and non-adult patients will be excluded. Baseline characteristics, comorbidities, laboratory data, disease severity, and ventilatory support will be retrospectively collected from clinical records. The indication of tracheostomy, as part of our standard of care, will be indicated by a team of specialists in intensive care medicine, following national guidelines, and consented to by the patient's family. The 90-days mortality rate will be the primary outcome, whereas IMV days, hospital/CU length of stay, and the frequency of healthcare-associated infections will be the secondary outcomes. Also, a follow-up interview will be performed one year after a hospital discharged in order to assess the vital status and quality of life.
The mortality of patients subjected to tracheostomy will be compared with the group of patients without tracheostomy by logistic regression models. Furthermore, propensity-score methods will be performed as a complementary analysis.
- Conditions
- Mechanical Ventilation, Covid19, Tracheostomy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ventilated patients subjected to tracheostomy | Patients who receive percutaneous or surgical tracheostomy due to prolonged mechanical ventilation. The indication is made by an experts team and based on national guidelines | |
| COVID-19 ventilated patients without tracheostomy | Patients supported with mechanical ventilation by 10 days or more in who an experts team of physicians decided do not perform a tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-days mortality rate
Death occurred during the follow-up
Measured: Since mechanical ventilation onset to death or 90-days follow-up
Secondary outcomes (5)
Hospital length of stay
Days from hospital admission to discharge
Measured: From hospital admission to discharge, up to 90 days
ICU length of stay
Days elapsed in the first ICU admission
Measured: From first ICU admission to transfer at a lower complexity unit, up to 90 days
Time of mechanical ventilation
Days of invasive ventilatory support
Measured: From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days
Health-care associated infections
Frequency of respiratory, urinary tract, blood stream and invasive device-related infections
Measured: From hospital admission to discharge, up to 90 days
Long-term quality of life assessed by Short Form-36 Health Survey, SF-36
Score on the the Short Form-36 Health Survey (SF-36). SF-36 is a 36-item questionary that assesses the quality of life on eight health-related aspects. It scores from 0 (maximum disability) to 100 (no disability): the lower the score the more disability.
Measured: One year after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start3 Mar 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Romero, MD., University of Chile
- Investigators
- Carlos Romero, MD, Principal investigator, Intensive Care Unit, Hospital Clínico Universidad de Chile, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642703
- Sponsor's protocol ID
- 65/20
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality in Patients With Severe SARS-CoV-2 Pneumonia Who Underwent Tracheostomy Due to Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04642703
- Acronym / sponsor ID
- 65/20
- Conditions
- Mechanical Ventilation, Covid19, Tracheostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 24 Nov 2020 (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.
Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. This study aims to compare in-hospital mortality in COVID-19 patients with and without tracheostomy due to prolonged IMV Methods: Cohort study of adult COVID-19 patients subjected to prolonged IMV. Since the first COVID-19 case (March 3, 2020) up to November 30, 2020, all adult critical patients supported with IMV by 10 days or more at the Hospital Clínico Universidad de Chile will be included in the cohort. Pregnant women and non-adult patients will be excluded. Baseline characteristics, comorbidities, laboratory data, disease severity, and ventilatory support will be retrospectively collected from clinical records. The indication of tracheostomy, as part of our standard of care, will be indicated by a team of specialists in intensive care medicine, following national guidelines, and consented to by the patient's family. The 90-days mortality rate will be the primary outcome, whereas IMV days, hospital/CU length of stay, and the frequency of healthcare-associated infections will be the secondary outcomes. Also, a follow-up interview will be performed one year after a hospital discharged in order to assess the vital status and quality of life.
The mortality of patients subjected to tracheostomy will be compared with the group of patients without tracheostomy by logistic regression models. Furthermore, propensity-score methods will be performed as a complementary analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ventilated patients subjected to tracheostomy | – | –Patients who receive percutaneous or surgical tracheostomy due to prolonged mechanical ventilation. The indication is made by an experts team and based on national guidelines |
| COVID-19 ventilated patients without tracheostomy | – | –Patients supported with mechanical ventilation by 10 days or more in who an experts team of physicians decided do not perform a tracheostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients with respiratory failure needing mechanical ventilation for 10 days or longer
Key inclusion criteria (2 listed)
- COVID-19 confirmed case
- Invasive mechanical ventilation by 10 days or longer
Key exclusion criteria (2 listed)
- Childhood
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-days mortality rate
Time frame: Since mechanical ventilation onset to death or 90-days follow-up
Death occurred during the follow-up
5 secondary outcomes
Hospital length of stay
Time frame: From hospital admission to discharge, up to 90 days
ICU length of stay
Time frame: From first ICU admission to transfer at a lower complexity unit, up to 90 days
Time of mechanical ventilation
Time frame: From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days
Health-care associated infections
Time frame: From hospital admission to discharge, up to 90 days
Long-term quality of life assessed by Short Form-36 Health Survey, SF-36
Time frame: One year after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Romero, MD principal investigator
Intensive Care Unit, Hospital Clínico Universidad de Chile, University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Covid19, run by University of Chile at 1 site in Chile.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Romero, MD (+56229788264, mvenegash@hcuch.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-days mortality rate (time frame: Since mechanical ventilation onset to death or 90-days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2020.