Tracheal Tube Cuff Shape and Pressure

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591769
• Other study ID #: 2020-10-002C
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dysphonia
• Intubation, Intratracheal
• Pain, Postoperative

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