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Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

M

Mahidol University

Status

Completed

Conditions

Intubation Complication

Treatments

Device: suction catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT05717907
2023/DT039

Details and patient eligibility

About

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?

Full description

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

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 2 patient groups

Control group
No Intervention group
Description:
conventional nasotracheal intubation procedure
Guided group
Experimental group
Description:
use suction catheter guided endotracheal tube through the nasal passage
Treatment:
Device: suction catheter

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Pattamon Leelachaikul, D.D.S.; Duangdee Rummasak, M.D.

Data sourced from clinicaltrials.gov

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