Tracheal Tube Cuff Shape and Pressure

Taipei Veterans General Hospital, Taiwan80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Intubation, Intratracheal Pain, Postoperative Dysphonia

Interventions

Different tracheal tube cuff designDEVICE

Comparison of effect between 2 different designs of tracheal tube cuff

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Just seal tracheal tube cuff pressure

Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system

Time frame: 1 minute after anesthesia and tracheal intubation

Tracheal tube cuff pressure on retractor splay

Cuff pressure when the retractors are set-up and removed

Time frame: Intraoperative monitoring

Secondary Outcomes

Sore throat-NRS

Postoperative sore throat, Numeric Rating Scale(NRS) 0\~10; 0=no sore throat; 10=maximal sore throat

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: One day before operation, and post operation day 7

Data from ClinicalTrials.gov

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