- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816435
Airway Ultrasound Assessment in the Prediction of Difficult Airway
March 23, 2021 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Review of Classical Predictors and Role of Airway Ultrasound in the Prediction of Difficult Airway
To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Madrid, Spain, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients under general anesthesia with orotracheal intubation
Description
Inclusion Criteria:
- Patients risk ASA I-IV
- Non-urgent surgery under general anesthesia with orotracheal intubation
- Acceptance to participate and grant written consent
Exclusion Criteria:
- Urgent surgery
- Patients with a history of craniocervical pathology (trauma, tumor, malformations)
- Pregnancy
- Patient Refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pretracheal fat thickness for intubation complexity
Time Frame: 5 minutes
|
The pretracheal fat at the level of the vocal cords will be evaluated with ultrasound, to discern if a certain thickness is related to a difficult laryngoscopic vision (understood as cormack 3 or 4)
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2021
Last Update Submitted That Met QC Criteria
March 23, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- FJD-ECOVAD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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