Tracheal Tube Cuff Shape and Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Dysphonia; Intubation, Intratracheal
• Intervention / Treatment: Device: Different tracheal tube cuff design

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: Ya-Chun Chu, MD, PhD, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Li YS, Tan EC, Tsai YJ, Mandell MS, Huang SS, Chiang TY, Huang WC, Chang WK, Chu YC. A Tapered Cuff Tracheal Tube Decreases the Need for Cuff Pressure Adjustment After Surgical Retraction During Anterior Cervical Spine Surgery: A Randomized Controlled, Double-Blind Trial. Front Med (Lausanne). 2022 Jun 29;9:920726. doi: 10.3389/fmed.2022.920726. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 11, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Pain, Postoperative; Dysphonia
• Other Study ID Numbers: 2020-10-002C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to yachunchu@gmail.com. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No