Tracheal Tube Cuff Shape and Pressure

NCT04591769 | Completed

• 1 other identifier: 2020-10-002C
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation, Intratracheal; Pain, Postoperative; Dysphonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Sore throat-NRS

  preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7

• Sore throat-VAS

  preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7

• Subjective dysphonia

  preOP day 1, post OP 2 hours, day 1, 2, 3, 7

• Subjective dysphonia-GRBAS score

  One day before operation, and post operation day 1

• Subjective dysphonia- Voice Handicap Index-10(VHI-10)

  One day before operation, and post operation day 7

Study Arms (2)

Group T(Tapered- shaped)

EXPERIMENTAL

Tracheal intubation using TaperedGuard Tracheal Tube

Device: Different tracheal tube cuff design

Group C(Cylindrical-shaped)

ACTIVE COMPARATOR

Tracheal intubation using Hi-Contour Tracheal Tube

Device: Different tracheal tube cuff design

Interventions

Different tracheal tube cuff design DEVICE

Comparison of effect between 2 different designs of tracheal tube cuff

Group C(Cylindrical-shaped); Group T(Tapered- shaped)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving elective anterior cervical spine surgery
• Right side approach

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35847807 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Dysphonia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases

Study Officials

• Ya-Chun Chu, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be intubated by an anesthesiologist who is aware of the grouping. After tracheal intubation is finished, the cuff is connected to the pressure monitor system and another blinded assessor will adjust and record the minimal volume that is required for sealing the tracheal tube-ventilator. The cuff pressure will be monitored and recorded all throughout the surgical period. A blinded assessor will follow up the patient after the surgery and do the voice analysis. Patients are unaware of the type of tracheal tube they used and will score subjectively for the sore throat and postoperative dysphonia.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ya-Chun Chu, MD, PhD, Division of Neuroanesthesia, Department of Anesthesiology

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 19, 2020
• Study Start: November 5, 2020
• Primary Completion: March 31, 2021
• Study Completion: June 30, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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.

Locations

TW (1)