N/A
N=52
Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia
Intubation Complication
Bottom Line
View on ClinicalTrials.gov: NCT05717907 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Extent of Bleeding — 12; 13; 3; 3 Participants — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- suction catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mahidol University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Bleeding |
12; 13; 3; 3; 4; 3 | 1.000 |
| PRIMARY Incidence of Bleeding |
12; 13; 14; 13 | — |
| SECONDARY Ease of Navigation |
20; 22; 2; 3; 4; 1 | — |
Summary
The goal of this clinical trial to study the efficacy of suction catheter guided technique and conventional technique during nasotracheal intubation.
The main question are
* How effective of the use of a suction catheter guided ETT in reducing bleeding during nasotracheal intubation?
* Does the use of a suction catheter guided ETT can improve its navigability through the nasal passage and reduce nasal passage time?
Eligibility Criteria
Inclusion Criteria
- Patient undergoing elective oral and maxillofacial surgery in which nasotracheal intubation is preferred over orotracheal intubation to optimize surgical access.
- ASA physical status I-II
- Thai adult, aged 18-65 years old
- Normal Body Mass Index (BMI = 18.5-24.9)
Exclusion Criteria
- Anticipated difficult airway (e.g., Mallampati classification 3-4, interincisal distance < 35 mm., thyromental length < 60 mm., limited neck mobility)
- Nasal infection or systemic infection
- Abnormal coagulation status or having bleeding disorder or taking anticoagulation/antiplatelet medication
- History of recurrent epistaxis since adulthood
- Allergic rhinitis that necessitates the use of glucocorticoids, antihistamine, antileukotriene or decongestant in the past 4 weeks
- History of nasal trauma or abnormality (e.g., trauma in mid-face region, nasal surgery, nasal polyps, chronic sinusitis, abnormal nasal vasculature, tumor in nasal region, radiotherapy in nasal region)
- Craniofacial deformity syndrome
- Using nasal oxygen or Continuous Positive Airway Pressure (CPAP)
- Previous nasotracheal intubation or nasogastric tube placement within 3 months
- Diagnosed as having a mental disorder
Drop-out criteria:
- Unable to complete intubation procedure
- Intubation failed on both nostrils
- When intubation was only possible with a tube smaller than 6.5 internal diameter (ID) in male and 6.0 ID in female
- Inadequate data collection
Data sourced from ClinicalTrials.gov (NCT05717907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.