Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Intubation Complication
• Intervention / Treatment: Device: suction catheter

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extent of bleeding	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	measured immediately after successful intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of navigation	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	measured immediately after successful intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts	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,...."	measured immediately after successful intubation
Nasal passage time	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"	measured immediately after successful intubation

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Duangdee Rummasak, M.D., faculty of dentistry, Mahidol university

Publications and helpful links

General Publications

• Kim YC, Lee SH, Noh GJ, Cho SY, Yeom JH, Shin WJ, Lee DH, Ryu JS, Park YS, Cha KJ, Lee SC. Thermosoftening treatment of the nasotracheal tube before intubation can reduce epistaxis and nasal damage. Anesth Analg. 2000 Sep;91(3):698-701. doi: 10.1097/00000539-200009000-00038.
• Anwer HM.F., Ibrahim AA. Suction catheter guidance of the endotracheal tube to facilitate nasal intubation: a double blind, randomized clinical trial. MEJA.2018;25 (2):155-63.
• Prasanna D, Bhat S. Nasotracheal Intubation: An Overview. J Maxillofac Oral Surg. 2014 Dec;13(4):366-72. doi: 10.1007/s12663-013-0516-5. Epub 2013 May 1.
• Jongcharoenkamon I, Juajarn T, Pisilp N. Does suction tube guiding reduce epistaxis from nasotracheal intubation? Mahasarakham Hospital Journal. 2020;17(3):210-7.
• Piepho T, Thierbach A, Werner C. Nasotracheal intubation: look before you leap. Br J Anaesth. 2005 Jun;94(6):859-60. doi: 10.1093/bja/aei146. Epub 2005 Apr 15.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023/DT039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No