- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05525754
Computed Tomography-Guided Nasotracheal Intubation Procedure
Effectiveness of Computed Tomography-Guided Nasotracheal Intubation Procedure on Predicting Tube Advancement Difficulty and Preventing Epistaxis: A Prospective Case-control Study
Background: Nasotracheal intubation can lead to severe complications like epistaxis with excessive bleeding. The advancement difficulty of the tube faced during nasal intubation is one of the fundamental causes of this condition. The present study aimed to evaluate the effectiveness of Computed tomography-guided nasotracheal intubation in predicting tube advancement difficulty and preventing epistaxis.
Material and Methods: 60 maxillofacial surgery patients were included in the study. The space where the tube will be passed in the internal nasal valve region was measured horizontally (distance between inferior concha and septum) and vertically (distance between inferior concha and hard palate) by Computed Tomography. The patients were divided into two groups, 'easy' (n=28) or 'difficult' (n=32), according to the effort required to advance the tube through the nasal passage.
ROC analysis was performed, and cut-off values were determined to reveal the distance values at which difficulty may be experienced while advancing the tube. The cut-off values were 1.09 cm and 0.39 cm for the vertically and horizontally distances, respectively.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kayseri, Turkey, 38039
- Seher Orbay Yaşlı
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 to 65 who underwent bimaxillary orthognathic surgery
- defined as ASA (American Society of Anesthesiology) I or II
Exclusion Criteria:
- The lack of preoperative CT scans
- airways evaluated and considered difficult by the anesthesiologist
- airways assessed and considered not appropriate for right angle endotracheal (RAE) tube with7.0 mm internal diameter
- history of sinusitis or head trauma
- anticoagulant therapy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Investigation of the relationship between internal nasal valve measurements and nasal advancement of the intubation tube
Time Frame: during intubation procedure
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The measurements were carried out from the coronal sections at 0.25 intervals.
Before intubation, the lower part of the nasal valve region, aka the narrowest area of the nasal passage, was measured by calculating the distance between the anterior border of the inferior concha and the septal cartilage.
Additionally, using the same section of the CT image, the distance between the inferior concha and the hard palate was measured
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during intubation procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018 /No:377
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
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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