ExtubationINNOVATENCT03468036
Intratracheal Suctioning and Oxygenation at Extubation
An observational study of Extubation, run by Jörg Schefold at 1 site in Switzerland.
Trial summary
Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with 100% O2 vs. 35% O2 with/without suctioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation
- What is being tested?
- none, does not apply
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Oct 2019to 1 Dec 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: ICU patients that undergo routine extubation
Who may be able to join
- All adult (≥18 years) ICU patients with routine extubation on the ICU during the 2-month observational interval.
Who cannot join
- Age < 18 years
- Patients on comfort therapy and/ or terminal extubation or accidental extubationtracheostomized patients
- Patients with refusal to general consent or withdrawal of general consent (DLF and/or internal database)
- Patients dying without next-of-kin available
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. of Intensive Care Medicine, University of Bern,
Bern, 3010
About this study
Official title: Intratracheal Suctioning and Oxygenation at Extubation (INnovATE)
Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with 100% O2 vs. 35% O2 with/without suctioning.
- Conditions
- Extubation
- Being tested
- none, does not apply
- Keywords
- critical illness, ICU, extubation, respiratory failure
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, does not applyOther
none: does not apply
| Study group | Role | What they receive |
|---|---|---|
| Extubation with 100% O2 | for further information please refer to study protocol Receives: Other: none, does not apply | |
| Extubation with 35% O2 | for further information please refer to study protocol Receives: Other: none, does not apply |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of patients with need for ongoing ventilatory support
Measured: 30 days max follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start7 Oct 2019
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies 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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jörg Schefold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jörg Schefold, Insel Gruppe AG, University Hospital Bern
- Investigators
- Joerg C Schefold, MD, Principal investigator, Inselspital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468036
- Sponsor's protocol ID
- INNOVATE
- Acronym
- INNOVATE
- Status last verified
- Jan 2023
- First submitted
- 9 Mar 2018
- Last updated
- 26 Jan 2023
- Results posted
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratracheal Suctioning and Oxygenation at Extubation (INnovATE)
- ClinicalTrials.gov ID
- NCT03468036
- Acronym / sponsor ID
- INNOVATE / INNOVATE
- Conditions
- Extubation
- Keywords
- critical illness, ICU, extubation, respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Jörg SchefoldUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 16 Mar 2018 (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.
Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with 100% O2 vs. 35% O2 with/without suctioning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation with 100% O2 | – | Other: none, does not applyfor further information please refer to study protocol |
| Extubation with 35% O2 | – | Other: none, does not applyfor further information please refer to study protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients that undergo routine extubation
Key inclusion criteria (1 listed)
- All adult (≥18 years) ICU patients with routine extubation on the ICU during the 2-month observational interval.
Key exclusion criteria (4 listed)
- Age < 18 years
- Patients on comfort therapy and/ or terminal extubation or accidental extubationtracheostomized patients
- Patients with refusal to general consent or withdrawal of general consent (DLF and/or internal database)
- Patients dying without next-of-kin available
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 |
|---|---|---|
| none, does not applynone: does not apply | Other | Extubation with 100% O2, Extubation with 35% O2 |
Primary outcome
Difference in proportion of patients with need for ongoing ventilatory support
Time frame: 30 days max follow-up
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 26 Jan 2023.
- 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.
Joerg C Schefold, MD principal investigator
Inselspital, University of Bern
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 Extubation, run by Jörg Schefold at 1 site in Switzerland.
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 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 26 Jan 2023. 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 Switzerland. 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?
Difference in proportion of patients with need for ongoing ventilatory support (time frame: 30 days max 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 26 Jan 2023; AzTrials last refreshed its copy on 4 Nov 2026.