Tracheal Tube Cuff Shape and Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery

NCT03240042

Pressure Injury Dysphonia Dysphagia

COMPLETED NA

Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery

NCT05420428

Hypopharyngeal Mean Pressure

COMPLETED NA

Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes

NCT04499222

Nasotracheal Intubation

UNKNOWN NA

Semirigid Cervical Collar and Nasotracheal Intubation by Glidescope in Cervical Spine Surgery

NCT03210922

Orthosis

COMPLETED NA

Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx

NCT05679128

Airway Management

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation, Intratracheal Pain, Postoperative Dysphonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group T(Tapered- shaped)

Tracheal intubation using TaperedGuard Tracheal Tube

Group Type EXPERIMENTAL

Different tracheal tube cuff design

Intervention Type DEVICE

Comparison of effect between 2 different designs of tracheal tube cuff

Group C(Cylindrical-shaped)

Tracheal intubation using Hi-Contour Tracheal Tube

Group Type ACTIVE_COMPARATOR

Different tracheal tube cuff design

Intervention Type DEVICE

Comparison of effect between 2 different designs of tracheal tube cuff

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Different tracheal tube cuff design

Comparison of effect between 2 different designs of tracheal tube cuff

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No