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Tracheal Tube Cuff Shape and Pressure

Primary Purpose

Intubation, Intratracheal, Pain, Postoperative, Dysphonia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Different tracheal tube cuff design
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intubation, Intratracheal

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group T(Tapered- shaped)

Group C(Cylindrical-shaped)

Arm Description

Tracheal intubation using TaperedGuard Tracheal Tube

Tracheal intubation using Hi-Contour Tracheal Tube

Outcomes

Primary Outcome Measures

Just seal tracheal tube cuff pressure
Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system
Tracheal tube cuff pressure on retractor splay
Cuff pressure when the retractors are set-up and removed

Secondary Outcome Measures

Sore throat-NRS
Postoperative sore throat, Numeric Rating Scale(NRS) 0~10; 0=no sore throat; 10=maximal sore throat
Sore throat-VAS
Postoperative sore throat, Visual Analogue Scale (VAS) 0~10; 0=no sore throat; 10=maximal sore throat
Subjective dysphonia
Hoarseness; Pitch; Loudness (0= none; 1= mild; 2= severe); compared with baseline
Subjective dysphonia-GRBAS score
GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) score (normal, slight, moderate, severe); compared with baseline
Subjective dysphonia- Voice Handicap Index-10(VHI-10)
VHI-10 questionnaire (0 best~40 worst; >15 may be abnormal)
Objective dysphonia
Software voice analysis; compared with baseline
Postoperative complication
Any postoperative complication related complication

Full Information

First Posted
October 10, 2020
Last Updated
September 11, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04591769
Brief Title
Tracheal Tube Cuff Shape and Pressure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Intratracheal, Pain, Postoperative, Dysphonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group T(Tapered- shaped)
Arm Type
Experimental
Arm Description
Tracheal intubation using TaperedGuard Tracheal Tube
Arm Title
Group C(Cylindrical-shaped)
Arm Type
Active Comparator
Arm Description
Tracheal intubation using Hi-Contour Tracheal Tube
Intervention Type
Device
Intervention Name(s)
Different tracheal tube cuff design
Intervention Description
Comparison of effect between 2 different designs of tracheal tube cuff
Primary Outcome Measure Information:
Title
Just seal tracheal tube cuff pressure
Description
Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system
Time Frame
1 minute after anesthesia and tracheal intubation
Title
Tracheal tube cuff pressure on retractor splay
Description
Cuff pressure when the retractors are set-up and removed
Time Frame
Intraoperative monitoring
Secondary Outcome Measure Information:
Title
Sore throat-NRS
Description
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
Title
Sore throat-VAS
Description
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
Title
Subjective dysphonia
Description
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
Title
Subjective dysphonia-GRBAS score
Description
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
Title
Subjective dysphonia- Voice Handicap Index-10(VHI-10)
Description
VHI-10 questionnaire (0 best~40 worst; >15 may be abnormal)
Time Frame
One day before operation, and post operation day 7
Title
Objective dysphonia
Description
Software voice analysis; compared with baseline
Time Frame
One day before operation(baseline), and post operation day 1
Title
Postoperative complication
Description
Any postoperative complication related complication
Time Frame
After operation to post operation day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Chun Chu, MD, PhD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35847807
Citation
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.
Results Reference
derived

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Tracheal Tube Cuff Shape and Pressure

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