Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia

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

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

Conditions
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Intubation Complication

Intervention / Treatment
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* Device: suction catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>conventional nasotracheal intubation procedure | |
| Experimental: Guided group<br>use suction catheter guided endotracheal tube through the nasal passage | Device: suction catheter<br>* 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.<br>|

What is the study measuring?
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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 |