Clinical trial NCT05717907: Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia
Official title: Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia: Randomized Clinical Trial of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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

Eligibility criteria: 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

Primary outcomes:
measure: Extent of Bleeding
timeFrame: measured from video recorded at insert to withdraw videolaryngoscope
measure: Incidence of Bleeding
timeFrame: measured immediately after successful intubation
Secondary outcomes:
measure: Ease of Navigation
timeFrame: measured immediately after successful intubation
Other outcomes:
measure: Number of Attempts
timeFrame: measured immediately after successful intubation
measure: Nasal Passage Time
timeFrame: measured immediately after successful intubation
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of Dentistry
state: Bangkok
Study officials:
affiliation: faculty of dentistry, Mahidol university
name: Duangdee Rummasak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Jongcharoenkamon I, Juajarn T, Pisilp N. Does suction tube guiding reduce epistaxis from nasotracheal intubation? Mahasarakham Hospital Journal. 2020;17(3):210-7.
citation: 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.
citation: 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.