Clinical trial NCT04591769: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Pain, Postoperative
Dysphonia
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Just seal tracheal tube cuff pressure
timeFrame: 1 minute after anesthesia and tracheal intubation
measure: Tracheal tube cuff pressure on retractor splay
timeFrame: Intraoperative monitoring
Secondary outcomes:
measure: Sore throat-NRS
timeFrame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
measure: Sore throat-VAS
timeFrame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
measure: Subjective dysphonia
timeFrame: preOP day 1, post OP 2 hours, day 1, 2, 3, 7
measure: Subjective dysphonia-GRBAS score
timeFrame: One day before operation, and post operation day 1
measure: Subjective dysphonia- Voice Handicap Index-10(VHI-10)
timeFrame: One day before operation, and post operation day 7
measure: Objective dysphonia
timeFrame: One day before operation(baseline), and post operation day 1
measure: Postoperative complication
timeFrame: After operation to post operation day 7
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ya-Chun Chu, MD, PhD
role: STUDY_CHAIR
References:
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.