Tracheal Tube Cuff Shape and Pressure

Study Overview
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Brief Summary
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This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.

Detailed Description
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High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.

Official Title
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Cuff Pressure During Surgical Retractor Splay and Postoperative Voice Outcome After Anterior Cervical Spine Surgery: Comparison Between Tapered-shaped and Conventional Cylindrical-shaped Endotracheal Tube

Conditions
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Intubation, Intratracheal, Pain, Postoperative, Dysphonia

Intervention / Treatment
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* Device: Different tracheal tube cuff design


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving elective anterior cervical spine surgery Right side approach Exclusion Criteria: Unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies) Anticipated difficult airway Facial anomaly that may hinder facemask ventilation Preoperative hoarseness or vocal cord palsy regardless of etiology Re-operation of cervical spine surgery or left side approach BMI >35 Operation field involved cervical spine C1 or C2 Unwilling to sign the informed consent Unwilling to finish the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group T(Tapered- shaped)<br>Tracheal intubation using TaperedGuard Tracheal Tube | Device: Different tracheal tube cuff design<br>* Comparison of effect between 2 different designs of tracheal tube cuff<br>|
| Active Comparator: Group C(Cylindrical-shaped)<br>Tracheal intubation using Hi-Contour Tracheal Tube | Device: Different tracheal tube cuff design<br>* Comparison of effect between 2 different designs of tracheal tube cuff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Just seal tracheal tube cuff pressure | Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system | 1 minute after anesthesia and tracheal intubation | 
| Tracheal tube cuff pressure on retractor splay | Cuff pressure when the retractors are set-up and removed | Intraoperative monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sore throat-NRS | Postoperative sore throat, Numeric Rating Scale(NRS) 0 10; 0=no sore throat; 10=maximal sore throat | preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 | 
| Sore throat-VAS | Postoperative sore throat, Visual Analogue Scale (VAS) 0 10; 0=no sore throat; 10=maximal sore throat | preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 | 
| Subjective dysphonia | Hoarseness; Pitch; Loudness (0= none; 1= mild; 2= severe); compared with baseline | preOP day 1, post OP 2 hours, day 1, 2, 3, 7 | 
| Subjective dysphonia-GRBAS score | GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) score (normal, slight, moderate, severe); compared with baseline | One day before operation, and post operation day 1 | 
| Subjective dysphonia- Voice Handicap Index-10(VHI-10) | VHI-10 questionnaire (0 best 40 worst; >15 may be abnormal) | One day before operation, and post operation day 7 | 
| Objective dysphonia | Software voice analysis; compared with baseline | One day before operation(baseline), and post operation day 1 | 
| Postoperative complication | Any postoperative complication related complication | After operation to post operation day 7 |