Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

NCT05717907 | Completed Results

• 1 other identifier: 2023/DT039
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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?

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (2)

• 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 from video recorded at insert to withdraw videolaryngoscope

• Incidence of Bleeding

  rate of incidence of bleeding * No Bleeding (Grade 0) * Bleeding (Grade 1, 2, 3)

  measured immediately after successful intubation

Secondary Outcomes (1)

• Ease of Navigation

  measured immediately after successful intubation

Other Outcomes (2)

• Number of Attempts

  measured immediately after successful intubation

• Nasal Passage Time

  measured immediately after successful intubation

Study Arms (2)

Control group

NO INTERVENTION

conventional nasotracheal intubation procedure

Guided group

EXPERIMENTAL

use suction catheter guided endotracheal tube through the nasal passage

Device: suction catheter

Interventions

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.

Guided group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Dentistry

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  PMID: 26224998 BACKGROUND

• Jongcharoenkamon I, Juajarn T, Pisilp N. Does suction tube guiding reduce epistaxis from nasotracheal intubation? Mahasarakham Hospital Journal. 2020;17(3):210-7.

  BACKGROUND

• 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.

  PMID: 10960403 BACKGROUND

• 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.

  PMID: 15833776 BACKGROUND

Results Point of Contact

• Title: Pattamon Leelachaikul
• Organization: Mahidol university

pattamonl@hotmail.com

+66863019830

Study Officials

• Duangdee Rummasak, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 8, 2023
• Study Start: September 5, 2023
• Primary Completion: June 9, 2024
• Study Completion: June 10, 2024
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)