Pain, Postoperative Clinical Trial
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
Verified date | September 2021 |
Source | Taipei Veterans General Hospital, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 30, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Tracheal tube cuff pressure on retractor splay | Cuff pressure when the retractors are set-up and removed | Intraoperative monitoring | |
Secondary | 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 | |
Secondary | Sore throat-VAS | Postoperative sore throat, Visual Analogue Scale (VAS) 0~10; 0=no sore throat; 10=maximal sore throat | preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Objective dysphonia | Software voice analysis; compared with baseline | One day before operation(baseline), and post operation day 1 | |
Secondary | Postoperative complication | Any postoperative complication related complication | After operation to post operation day 7 |
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