Tracheal Tube Cuff Shape and Pressure

Not Applicable

Completed

• Conditions: Pain, Postoperative; Dysphonia; Intubation, Intratracheal
• Interventions: Device: Different tracheal tube cuff design

• Registration Number: NCT04591769
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-19
• Study Start: 2020-11-05
• Primary Completion: 2021-03-31
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-11
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C(Cylindrical-shaped)	Different tracheal tube cuff design	Tracheal intubation using Hi-Contour Tracheal Tube
Group T(Tapered- shaped)	Different tracheal tube cuff design	Tracheal intubation using TaperedGuard Tracheal Tube

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan