Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T(Tapered- shaped) | Experimental | Tracheal intubation using TaperedGuard Tracheal Tube |
|
| Group C(Cylindrical-shaped) | Active Comparator | Tracheal intubation using Hi-Contour Tracheal Tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Different tracheal tube cuff design | Device | Comparison of effect between 2 different designs of tracheal tube cuff |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tracheal tube cuff pressure on retractor splay | Cuff pressure when the retractors are set-up and removed | Intraoperative monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sore throat-VAS | Postoperative sore throat, Visual Analogue Scale (VAS) 0~10; 0=no sore throat; 10=maximal sore throat |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ya-Chun Chu, MD, PhD | Taipei Veterans General Hospital, Taiwan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35847807 | Derived | 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. |
Not provided
Not provided
All of the individual participant data collected during the trial, after deidentification.
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to yachunchu@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 |
| 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 |
| 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 |
| 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 |
| Objective dysphonia | Software voice analysis; compared with baseline | One day before operation(baseline), and post operation day 1 |
| Postoperative complication | Any postoperative complication related complication | After operation to post operation day 7 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009422 | Nervous System Diseases |