Obstructive Sleep Apnea
Conditions
Brief summary
This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. All the investigators are well trained and have received proof of training after completing the training program for da Vinci SP system provided by Intuitive.
Detailed description
This study will be conducted in Chang Gung Memorial Hospital at Linkou. Informed consent will be provided to patient who has an indication of surgical treatment for OSA. Study participants will sign an informed consent before any study procedure begins. Eligibilities will be assessed during screening period (2 weeks) with blood test and other routine assessments. Eligible patient will undergo surgical intervention using da Vinci SP Surgical System. Post-operation follow-up will be performed at 1 week, 1 month, 3 months, and 6 months.
Interventions
DEVICEDa Vinci SP Surgical System, Model SP1098
The da Vinci SP Surgical System is intended to assist in the accurate control of the da Vinci SP endoscope and instruments during minimally invasive endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, and breast surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or more. 2. OSA with AHI ≥ 15 3. Has failed, refuses, or is unable to tolerate CPAP therapy 4. Indication of resection of tongue base with/without other invasive surgical procedure for OSA (i.e. tongue base resection only or multi-level surgery with tongue base resection) 5. ASA physical status classification 1-2 and adequate organ function 6. Patients willing and able to comply with study protocol requirements and follow-up 7. Informed consent
Exclusion criteria
1. BMI\>35 2. Mouth opening too narrow for TORS or trismus 3. Betel nut chewing 4. Suspicious cancer diagnosis 5. Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed) 6. Other medical condition or anatomical factor not suitable for TORS, including subject with congenital malformations in the larynx, throat or tongue; 1. Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation 7. Active infectious disease 8. Can't follow trial-required procedures 9. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions * Severe heart disease (NYHA functional class III-IV) * Severe lung disease (GOLD Group C-D) 10. Long-term use of anti-coagulant 11. Patients with coagulopathy 12. Emergency surgery 13. Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used 14. Subject is pregnant or suspected to be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate | 3 months (+60 days) post-surgery | Success of tongue base resection without conversion to alternative surgery |
| Apena Hypopnea Index | 3 months (+60 days) post-surgery | Type I PSG measurements demonstrating Apena Hypopnea Index (AHI) reduction. An AHI of \< 20 events/hour and a reduction in AHI of 50% or greater from baseline levels will be defined as success, when evaluated at 3 months (+60 days) post-surgery. Although it does not meet these criteria, it can be interpreted as an improved result when AHI is improved after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Snoring Scale | 3 months (+60 days) post-surgery | Snoring VAS |
| Complication rate | 30 days | Rate, intraoperative and/or postoperative, Clavien system |
| Readmission rate | 30 days | Readmission rate |
| Reoperation rate | 30 days | Reoperation rate |
| Adverse Events | within 3 months (+60 days) post-surgery | Assessment of all reported adverse events (AE) within 3 months, (+60 days) post-surgery. Summarizing the incidence and frequency of all reported adverse events and categorizing them using CTCAE. |
| Pittsburgh Sleep Quality Index (PSQI) | at 1, 3, 6 months post-surgery | Pittsburgh Sleep Quality Index (PSQI) at 1, 3, 6 months post-surgery compared to baseline. |
| Perioperative mortality | 30 days | Perioperative mortality |
| Volume of resected tissue | 3 months (+60 days) post-surgery | measured using the volume displacement method |
| Pain score | 3 months (+60 days) post-surgery | Pain score (VAS) |
| Sleepiness Scale | 3 months (+60 days) post-surgery | Epworth Sleepiness Scale (ESS) and Stanford Sleepiness Scale (SSS) at 3 months (+60 days) post-surgery compared to baseline |
| Multi-level surgery | Intraoperative | Multi-level surgery (procedure used) |
| Operative time | Intraoperative | Operative time (first skin incision to closure of wound) |
| Console time | 3 months (+60 days) post-surgery | Console time |
| Transfusion and estimated blood loss | 3 months (+60 days) post-surgery | Transfusion and estimated blood loss |
| Length of hospital stay | 3 months (+60 days) post-surgery | Length of hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentages of sleep time | 3 months (+60 days) post-surgery | Percent sleep time below 90% oxygen saturation (ST90) at 3 months (+60 days) post-surgery compared to baseline. |
| Imaging analysis | 3 months (+60 days) post-surgery | Imaging analysis for resected tissue volume |
| Lowest oxygen saturation (LSAT) | 3 months (+60 days) post-surgery | Lowest oxygen saturation (LSAT), at 3 months (+60 days) post-surgery compared to baseline. |
| Percentages of sleep stages | 3 months (+60 days) post-surgery | Percentages of sleep stages (N1, N2, N3, R), at 3 months (+60 days) post-surgery compared to baseline. |
Countries
Taiwan
Contacts
Primary ContactTuan-Jen Fang
Outcome results
None listed