Intubation in ICUC-TOPNCT03888430
Transcutaneous PCO2 Assessment During Intubation in ICU
An observational study of Intubation in ICU, run by Rennes University Hospital at 1 site in France.
Trial summary
PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation in ICU
- What is being tested?
- PtcCO2 measure during intubation
- Type of treatment
- Surgery or procedure
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2018to 13 Apr 2019
- 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: ICU patients requiring intubation
Who may be able to join
- Adult patient 18 years of age or older
- Requiring intubation in Resuscitation
Who cannot join
- Contraindication to orotracheal intubation
- Intubation in a respiratory or cardiocirculatory arrest situation
- Need for intubation in great urgency preventing the installation of the transcutaneous capnia sensor and its calibration
- Major Incapable
- Opposition of the patient or his relatives to the research
Trial locations and contacts
1 site in 1 country.
About this study
PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.
Read the detailed description
Transcutaneous PCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods and hemodynamic changes during this period.
- Conditions
- Intubation in ICU
- Being tested
- PtcCO2 measure during intubation
- Keywords
- Transcutaneous PCO2, Preoxygenation, Post-intubation hypotension, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PtcCO2 measure during intubationProcedure or surgery
Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature
| Study group | Role | What they receive |
|---|---|---|
| Standard Oxygen | preoxygenation methods : Standard Oxygen Receives: Procedure: PtcCO2 measure during intubation | |
| High flow Oxygen | preoxygenation methods : High flow Oxygen Receives: Procedure: PtcCO2 measure during intubation | |
| Non invasive ventilation | preoxygenation methods : Non invasive ventilation Receives: Procedure: PtcCO2 measure during intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous carbon dioxide partial pressure variation during intubation
Transcutaneous carbon dioxide partial pressure (TcPO2) variation during intubation in ICU and within 4 hours after intubation
Measured: 4 hours after intubation (the day of inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start17 May 2018
- Primary completion16 Mar 2019
- Study completion13 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation in ICUStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien FREROU, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888430
- Sponsor's protocol ID
- 35RC18_3030_C-TOP
- Acronym
- C-TOP
- Status last verified
- Oct 2019
- First submitted
- 14 Mar 2019
- Last updated
- 28 Oct 2019
- 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 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous PCO2 Assessment During Intubation in ICU
- ClinicalTrials.gov ID
- NCT03888430
- Acronym / sponsor ID
- C-TOP / 35RC18_3030_C-TOP
- Conditions
- Intubation in ICU
- Keywords
- Transcutaneous PCO2, Preoxygenation, Post-intubation hypotension, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 16 Mar 2019 (actual)
- Study completion
- 13 Apr 2019 (actual)
- First posted
- 25 Mar 2019 (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.
PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.
Detailed description
Transcutaneous PCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods and hemodynamic changes during this period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Oxygen | – | Procedure: PtcCO2 measure during intubationpreoxygenation methods : Standard Oxygen |
| High flow Oxygen | – | Procedure: PtcCO2 measure during intubationpreoxygenation methods : High flow Oxygen |
| Non invasive ventilation | – | Procedure: PtcCO2 measure during intubationpreoxygenation methods : Non invasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ICU patients requiring intubation
Key inclusion criteria (2 listed)
- Adult patient 18 years of age or older
- Requiring intubation in Resuscitation
Key exclusion criteria (5 listed)
- Contraindication to orotracheal intubation
- Intubation in a respiratory or cardiocirculatory arrest situation
- Need for intubation in great urgency preventing the installation of the transcutaneous capnia sensor and its calibration
- Major Incapable
- Opposition of the patient or his relatives to the research
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 |
|---|---|---|
| PtcCO2 measure during intubationTranscutaneous measure during intubation. Non invasive measure without any risk according to the literature | Procedure or surgery | High flow Oxygen, Non invasive ventilation, Standard Oxygen |
Primary outcome
Transcutaneous carbon dioxide partial pressure variation during intubation
Time frame: 4 hours after intubation (the day of inclusion)
Transcutaneous carbon dioxide partial pressure (TcPO2) variation during intubation in ICU and within 4 hours after intubation
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 28 Oct 2019.
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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.
Aurélien FREROU, MD principal investigator
Rennes University Hospital
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 Intubation in ICU, run by Rennes University Hospital 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 2 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 28 Oct 2019. 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?
Transcutaneous carbon dioxide partial pressure variation during intubation (time frame: 4 hours after intubation (the day of inclusion)). 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 28 Oct 2019.