COVID-19STRATICNCT04799691
Comparison of 2 Ventilatory Support Strategies During Coronavirus Disease 2019 (Covid-19) Pneumonia
An observational study of COVID-19, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
This retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway… 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?
- Invasive ventilation strategy and Non-invasive ventilation strategies
- Type of treatment
- Surgery or procedure
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 15 Jan 2022
- 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: Patients with COVID 19 acute hypoxemic respiratory failure admitted in Hospital Sainte Musse ICU in 2020
Who may be able to join
- Patient with confirmed SARS COV2 infection
- Acute Respiratory Distress Syndrome
- Patient more than 18 year old
Who cannot join
- Intensive Care Unit admission for extra pulmonary failure
- "Do Not Reanimated" order
- Patient from another Intensive Care Unit
- Patient objection
- Judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 2 Ventilatory Support Strategies in Patients With Covid-19 Pneumonia Admitted in ICU : Retrospective Monocentric Study
This retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone Position) used during the second period.
- Conditions
- COVID-19
- Being tested
- Invasive ventilation strategy, Non-invasive ventilation strategies
- Keywords
- Invasive strategy, Non-invasive strategy, Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone position
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive ventilation strategyProcedure or surgery
Use of an invasive ventilatory support strategy
Non-invasive ventilation strategiesProcedure or surgery
Use of non-invasive ventilatory support strategies
| Study group | Role | What they receive |
|---|---|---|
| Invasive strategy group | Patients admitted in ICU with Covid-19 related pneumonia during COVID19 first period. Receives: Procedure: Invasive ventilation strategy | |
| Non-invasive strategy group | Patients admitted in ICU with Covid-19 related pneumonia during COVID19 second period. Receives: Procedure: Non-invasive ventilation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in ICU
Number of days spent in ICU
Measured: At the moment of ICU discharge or death, up to 3 month
Secondary outcomes (2)
Mortality
Rate of patients alive at the moment of intensive care unit discharge
Measured: At the moment of ICU discharge or death, up to 3 month
Complications
Number of complications during intensive care unit stay
Measured: At the moment of ICU discharge or death, up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Feb 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aude Garnero, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799691
- Sponsor's protocol ID
- 2021-CHITS-004
- Acronym
- STRATIC
- Status last verified
- Oct 2022
- First submitted
- 15 Mar 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Ventilatory Support Strategies in Patients With Covid-19 Pneumonia Admitted in ICU : Retrospective Monocentric Study
- ClinicalTrials.gov ID
- NCT04799691
- Acronym / sponsor ID
- STRATIC / 2021-CHITS-004
- Conditions
- COVID-19
- Keywords
- Invasive strategy, Non-invasive strategy, Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 16 Mar 2021 (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 retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone Position) used during the second period.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive strategy group | – | Procedure: Invasive ventilation strategyPatients admitted in ICU with Covid-19 related pneumonia during COVID19 first period. |
| Non-invasive strategy group | – | Procedure: Non-invasive ventilation strategiesPatients admitted in ICU with Covid-19 related pneumonia during COVID19 second period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID 19 acute hypoxemic respiratory failure admitted in Hospital Sainte Musse ICU in 2020
Key inclusion criteria (3 listed)
- Patient with confirmed SARS COV2 infection
- Acute Respiratory Distress Syndrome
- Patient more than 18 year old
Key exclusion criteria (5 listed)
- Intensive Care Unit admission for extra pulmonary failure
- "Do Not Reanimated" order
- Patient from another Intensive Care Unit
- Patient objection
- Judicial protection
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 |
|---|---|---|
| Invasive ventilation strategyUse of an invasive ventilatory support strategy | Procedure or surgery | Invasive strategy group |
| Non-invasive ventilation strategiesUse of non-invasive ventilatory support strategies | Procedure or surgery | Non-invasive strategy group |
Primary outcome
Length of stay in ICU
Time frame: At the moment of ICU discharge or death, up to 3 month
Number of days spent in ICU
2 secondary outcomes
Mortality
Time frame: At the moment of ICU discharge or death, up to 3 month
Complications
Time frame: At the moment of ICU discharge or death, up to 3 month
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 12 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Aude Garnero, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
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 COVID-19, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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 5 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 12 Oct 2022. 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 France. 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?
Length of stay in ICU (time frame: At the moment of ICU discharge or death, up to 3 month). 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 12 Oct 2022.