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Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

Not Applicable
Completed
Conditions
Intubation Complication
Interventions
Device: suction catheter
Registration Number
NCT05717907
Lead Sponsor
Mahidol University
Brief 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?

Detailed Description

Study design Clinical trial: Prospective randomized controlled trial with equal randomization (1:1), double-blinded (Participant and Primary outcome assessor), parallel design

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Guided groupsuction catheteruse suction catheter guided endotracheal tube through the nasal passage
Primary Outcome Measures
NameTimeMethod
Extent of Bleedingmeasured from video recorded at insert to withdraw videolaryngoscope

The video from video laryngoscope will be recorded at the moment during and immediately after successful intubation, which will be later reviewed by primary outcome assessor that not involved in the procedure. Accounting for only bleeding observed at posterior pharyngeal area, which originate from trauma from attempt to pass ETT through the nasal passage into the pharynx. Assessment of bleeding will be scored at the most severe bleeding state observed from inserting to the removal of video laryngoscope after successful intubation. The extent of bleeding will be graded as:

"Grade 0" = no bleeding "Grade 1" = blood-stained tube and/or cuff "Grade 2" = blood-stained posterior pharyngeal wall (traces or streak of blood) "Grade 3" = blood pooling at posterior pharyngeal wall

Incidence of Bleedingmeasured immediately after successful intubation

rate of incidence of bleeding

* No Bleeding (Grade 0)

* Bleeding (Grade 1, 2, 3)

Secondary Outcome Measures
NameTimeMethod
Ease of Navigationmeasured immediately after successful intubation

Ease of navigation during advancement of tube though the nasal passage, will be recorded as "Smooth" = ETT meet no resistance, no need to adjust the tube "Slight resistance" = ETT meet the resistance and has to be manipulated more than once "Impinged" = ETT cannot pass through and need to move to another nostril

Trial Locations

Locations (1)

Faculty of Dentistry

🇹🇭

Ratchathewi, Bangkok, Thailand

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