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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04591769
Other study ID # 2020-10-002C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2020
Est. completion date June 30, 2021

Study information

Verified date September 2021
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 30, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Different tracheal tube cuff design
Comparison of effect between 2 different designs of tracheal tube cuff

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Tracheal tube cuff pressure on retractor splay Cuff pressure when the retractors are set-up and removed Intraoperative monitoring
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Objective dysphonia Software voice analysis; compared with baseline One day before operation(baseline), and post operation day 1
Secondary Postoperative complication Any postoperative complication related complication After operation to post operation day 7
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