Sars-CoV2TubeObs-CovidNCT04394429
Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation
An observational study of Sars-CoV2, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2020to 24 Jun 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
- Adult, Older adult
Study population: Subject with COVID 19 hospitalized in the intensive care unit at the NHC of the University Hospitals of Strasbourg
Who may be able to join
- Major Subject (≥18 years)
- Subject with COVID 19 (radiological suspicion or microbiological confirmation)
- Subject hospitalised in the intensive care unit at the NHC of the University Hospitals of Strasbourg between 01/03/2020 and 03/04/2020.
- Subject treated by mechanical ventilation
- Subject who has not expressed his opposition, after information, to the re-use of his data for the purposes of this research
- Translated with www.DeepL.com/Translator (free version)
Who cannot join
- Subject who expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguarding of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil
Strasbourg, 67091
Bob HEGER, MD, 33 3.69.55.04.43, Bob.Heger@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Analysis of Events of Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation
The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.
- Conditions
- Sars-CoV2
- Keywords
- Endotracheal Tube, ETT, Intubation, Mechanical ventilation, Endotracheal tube obstruction, ICU, Covid-19, SARS-CoV-2, ARDS
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of risk factors for intubation tube obstruction
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start24 Apr 2020
- Primary completion24 Jun 2021 (estimated)
- Study completion24 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 only
- Time perspective
- Other
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bob HEGER, Study director, Anesthesia-Resuscitation Department - Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394429
- Sponsor's protocol ID
- 7803
- Acronym
- TubeObs-Covid
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Events of Endotracheal Tube Obstruction in Covid-19 Patients Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04394429
- Acronym / sponsor ID
- TubeObs-Covid / 7803
- Conditions
- Sars-CoV2
- Keywords
- Endotracheal Tube, ETT, Intubation, Mechanical ventilation, Endotracheal tube obstruction, ICU, Covid-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 24 Jun 2021 (estimated)
- Study completion
- 24 Jun 2021 (estimated)
- First posted
- 19 May 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.
The COVID-19 pandemic is very present in our region, the Grand-Est region is considered as one of the first COVID-19 epicentres in France. COVID-19 causes an acute respiratory distress syndrome requiring prolonged mechanical ventilation in resuscitation.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subject with COVID 19 hospitalized in the intensive care unit at the NHC of the University Hospitals of Strasbourg
Key inclusion criteria (6 listed)
- Major Subject (≥18 years)
- Subject with COVID 19 (radiological suspicion or microbiological confirmation)
- Subject hospitalised in the intensive care unit at the NHC of the University Hospitals of Strasbourg between 01/03/2020 and 03/04/2020.
- Subject treated by mechanical ventilation
- Subject who has not expressed his opposition, after information, to the re-use of his data for the purposes of this research
Key exclusion criteria (2 listed)
- Subject who expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguarding of justice
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
Analysis of risk factors for intubation tube obstruction
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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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.
Bob HEGER study director
Anesthesia-Resuscitation Department - Strasbourg University Hospitals
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 Sars-CoV2, run by University Hospital, Strasbourg, France 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 6 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 8 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bob HEGER, MD (33 3.69.55.04.43, Bob.Heger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of risk factors for intubation tube obstruction (time frame: 1 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 8 Jan 2021.