- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06453525
PrediSuisse: Automatized Assessment of Difficult Airway (PrediSuisse)
PrediSuisse: Automatized Assessment of Difficult Airway Using Three Videolaryngoscopes With the Help of Facial Recognition Techniques and Neural Network
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Patrick Schoettker, PhD
- Phone Number: +41213142007
- Email: patrick.schoettker@chuv.ch
Study Locations
-
-
-
Lausanne, Switzerland, 1011
- Recruiting
- University Hospital Lausanne CHUV
-
Contact:
- Patrick Schoettker, PhD
- Phone Number: +41213142007
- Email: patrick.schoettker@chuv.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (≥ 18 years old) presenting at the pre-anesthesia consult for an elective general anesthesia necessitating a tracheal intubation
- Signed informed consent.
Exclusion Criteria:
- Patients not speaking French (in Geneva and Lausanne) or Italian (in Lugano).
- Patients previously operated on the airway with anatomical modifications (ENT Flaps, tracheotomies).
- Patients unable to follow procedures or to give consent will also be excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
C-mac
Intubation performed with a C-Mac videolaryngoscope
|
Tracheal intubation using one of the three existing videolaryngoscopes
|
|
MacGrath
Intubation performed with a MacGrath videolaryngoscope
|
Tracheal intubation using one of the three existing videolaryngoscopes
|
|
Airtraq
Intubation performed with an Airtraq videolaryngoscope
|
Tracheal intubation using one of the three existing videolaryngoscopes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Software creation
Time Frame: 18 months
|
The primary outcome is to create a reliable, reproducible, ultra-portable and radiation-free automated software, capable of identifying automatically collected features such as facial characteristics, mouth opening, range of motion while moving the neck and thyromental distance to predict intubation difficulty. The identification of the difficult intubation score will be compared by the one goven independantly by three airway experts. |
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Team Communication
Time Frame: 18 months
|
The secondary outcome is to evaluate the impact of streaming images of the intubations acquired by the videolaryngoscopy directly to the screens located in the operating room (OR) on communication between healthcare professionals in the OR with the help of a dedicated questionnaire.
|
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick Schoettker, PhD, Centre Hospitalier Universitaire Vaudois
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04062024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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