Dysphonia, Intubation, Intratracheal, Pain, Postoperative
Conditions
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.
Interventions
DEVICEDifferent tracheal tube cuff design
Comparison of effect between 2 different designs of tracheal tube cuff
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Just seal tracheal tube cuff pressure | 1 minute after anesthesia and tracheal intubation | Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system |
| Tracheal tube cuff pressure on retractor splay | Intraoperative monitoring | Cuff pressure when the retractors are set-up and removed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective dysphonia | preOP day 1, post OP 2 hours, day 1, 2, 3, 7 | Hoarseness; Pitch; Loudness (0= none; 1= mild; 2= severe); compared with baseline |
| Subjective dysphonia-GRBAS score | One day before operation, and post operation day 1 | GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) score (normal, slight, moderate, severe); compared with baseline |
| Sore throat-NRS | preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 | Postoperative sore throat, Numeric Rating Scale(NRS) 0\ 10; 0=no sore throat; 10=maximal sore throat |
| Objective dysphonia | One day before operation(baseline), and post operation day 1 | Software voice analysis; compared with baseline |
| Postoperative complication | After operation to post operation day 7 | Any postoperative complication related complication |
| Subjective dysphonia- Voice Handicap Index-10(VHI-10) | One day before operation, and post operation day 7 | VHI-10 questionnaire (0 best\ 40 worst; \>15 may be abnormal) |
| Sore throat-VAS | preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 | Postoperative sore throat, Visual Analogue Scale (VAS) 0\ 10; 0=no sore throat; 10=maximal sore throat |
Countries
Taiwan
Outcome results
None listed