Tracheal Tube Cuff Shape and Pressure

Taipei Veterans General Hospital

Status: Completed

Conditions: Intubation, Intratracheal; Pain, Postoperative; Dysphonia

Treatments: Device: Different tracheal tube cuff design

Study type: Interventional

Funder types: Other

Identifiers

NCT04591769

2020-10-002C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group T(Tapered- shaped)

Experimental group

Description:

Tracheal intubation using TaperedGuard Tracheal Tube

Treatment:

Device: Different tracheal tube cuff design

Group C(Cylindrical-shaped)

Active Comparator group

Description:

Tracheal intubation using Hi-Contour Tracheal Tube

Treatment:

Device: Different tracheal tube cuff design