Tracheal IntubationPhase 4GICACNCT02404142
Curarisation and Intubation Conditions During Videolaryngoscopy With Glidescope Titanium
A Phase 4 study testing Curare (Atracurium) and saline isotonic solution in people with Tracheal Intubation, run by CHU de Reims at 1 site in France.
Trial summary
In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium) group) or no (control group) within elective surgery patients with no difficult intubation prediction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Curare (Atracurium) and saline isotonic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2015to 5 Aug 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Elective Surgery Adult Patients
- no difficult intubation prediction
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium) group) or no (control group) within elective surgery patients with no difficult intubation prediction
Read the detailed description
In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium)group) or no (control group) within elective surgery patients with no difficult intubation prediction. The IDS score assessed by an anesthesiologist from the video-recording is the primary outcome. All general anesthesias are standardized using Target Control Infusion of propofol and sufentanil. The investigators also compare IDS scores as assessed by intubators, time for tracheal intubation, and laryngeal morbidity in both groups.
- Conditions
- Tracheal Intubation
- Being tested
- Curare (Atracurium), saline isotonic solution
- Keywords
- Trachel intubation, IDS score, Videoaryngoscopy, Glidescope® Titanium®, NMBA, Curare (Atracurium)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curare (Atracurium)Drug
Curare (Atracurium) versus saline isotonic solution for tracheal intubation
saline isotonic solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Control group (saline isotonic solution) | Placebo comparator | saline isotonic solution Receives: Drug: saline isotonic solution |
| Curar (Atracurium) group | Experimental | Curar (Atracurium) Receives: Drug: Curare (Atracurium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IDS score video-assessed as described by Adnet et al. Measurement will be made by 2 experts anesthesiologists for centralized reading
Number of IDS scores <2 are compared
Measured: Assessment will be done at the end of the inclusions period (9 months)
Secondary outcomes (1)
IDS score assesed by the intubator anesthesiologist
Measured: 3 days post intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start20 Feb 2015
- Primary completion5 Apr 2016
- Study completion5 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Collaborators
- Verathon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404142
- Sponsor's protocol ID
- PI14034
- Acronym
- GICAC
- Status last verified
- Jan 2018
- First submitted
- 17 Mar 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curarisation and Intubation Conditions During Videolaryngoscopy With Glidescope Titanium
- ClinicalTrials.gov ID
- NCT02404142
- Acronym / sponsor ID
- GICAC / PI14034
- Conditions
- Tracheal Intubation
- Keywords
- Trachel intubation, IDS score, Videoaryngoscopy, Glidescope® Titanium®, NMBA, Curare (Atracurium)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Collaborators
- Verathon
- Study start
- 20 Feb 2015
- Primary completion
- 5 Apr 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium) group) or no (control group) within elective surgery patients with no difficult intubation prediction
Detailed description
In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium)group) or no (control group) within elective surgery patients with no difficult intubation prediction. The IDS score assessed by an anesthesiologist from the video-recording is the primary outcome. All general anesthesias are standardized using Target Control Infusion of propofol and sufentanil. The investigators also compare IDS scores as assessed by intubators, time for tracheal intubation, and laryngeal morbidity in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (saline isotonic solution) | Placebo comparator | Drug: saline isotonic solutionsaline isotonic solution |
| Curar (Atracurium) group | Experimental | Drug: Curare (Atracurium)Curar (Atracurium) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective Surgery Adult Patients
- no difficult intubation prediction
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Curare (Atracurium)Curare (Atracurium) versus saline isotonic solution for tracheal intubation | Drug | Curar (Atracurium) group |
| saline isotonic solution | Drug | Control group (saline isotonic solution) |
Primary outcome
IDS score video-assessed as described by Adnet et al. Measurement will be made by 2 experts anesthesiologists for centralized reading
Time frame: Assessment will be done at the end of the inclusions period (9 months)
Number of IDS scores <2 are compared
1 secondary outcome
IDS score assesed by the intubator anesthesiologist
Time frame: 3 days post 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 9 Jan 2018.
Related trials for Tracheal Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Curare (Atracurium) and saline isotonic solution in people with Tracheal Intubation, run by CHU de Reims 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 0 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 9 Jan 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
IDS score video-assessed as described by Adnet et al. Measurement will be made by 2 experts anesthesiologists for centralized reading (time frame: Assessment will be done at the end of the inclusions period (9 months)). 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 9 Jan 2018.