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Completed

NCT Number: NCT05717907

Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

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?

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Key information

Conditions

Intubation Complication

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Ratchathewi, Bangkok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suction catheter

Device

a suction catheter will be first inserted through the ETT so that about 10 cm of the catheter was protruding from the distal end of the tube. The tip of the catheter is then inserted through the selected nostril until it passes to the pharynx. If resistance is felt to the passage of catheter, the other nostril will be tried. The nostril with less resistance to the catheter passage will be chosen for the completion of the procedure. The Endotracheal tube is then advance over the catheter through the nasal passage while holding the catheter proximal to the tube to prevent its advancement with the tube. After the tube tip reach to the pharynx, the suction catheter is withdrawn and tracheal intubation will be completed.

Primary outcomes

  1. Extent of Bleeding

    Time frame: measured 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

  2. Incidence of Bleeding

    Time frame: measured immediately after successful intubation

    rate of incidence of bleeding

    • No Bleeding (Grade 0)
    • Bleeding (Grade 1, 2, 3)

Secondary outcomes

  1. Ease of Navigation

    Time frame: measured 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

Other outcomes

  1. Number of Attempts

    Time frame: measured immediately after successful intubation

    The outcome will be recorded as "1,2,3,...." Number of insertion attempt to pass the nasal passage in each participants.

  2. Nasal Passage Time

    Time frame: measured immediately after successful intubation

    • Control group: starting when the tip of the ETT just enter the anterior nares until the tip of the ETT just pass the posterior nares and entered the pharynx
    • Guided group: starting when the tip of the guiding suction catheter just entered the anterior nares until the tip of the ETT passed the posterior nares, then entered the pharynx and the guiding catheter was completely removed from the ETT.

    The outcome will be recorded in "unit of seconds"

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia: Randomized Clinical Trial of Efficacy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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