Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05717907
Collaborator
(none)
52
2
18

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Device: suction catheter
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia: Randomized Clinical Trial of Efficacy
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

conventional nasotracheal intubation procedure

Experimental: Guided group

use suction catheter guided endotracheal tube through the nasal passage

Device: suction catheter
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 After the tube tip reach to the pharynx, the suction catheter is withdrawn and tracheal intubation will be completed.

Outcome Measures

Primary Outcome Measures

  1. extent of bleeding [measured immediately after successful intubation]

    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

Secondary Outcome Measures

  1. Ease of navigation [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 Outcome Measures

  1. Number of attempts [measured immediately after successful intubation]

    number of attempts of the tube needed to withdraw completely before successful nasal passage pass-through, in order to find new angulation or change nostril or decrease tube size. The outcome will be recorded as "1,2,3,...."

  2. Nasal passage time [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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duangdee Rummasak, Assoc. Prof., Mahidol University
ClinicalTrials.gov Identifier:
NCT05717907
Other Study ID Numbers:
  • MahidolUni
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 8, 2023