Other Complications of Surgical and Medical Procedures
Conditions
Keywords
Jet Ventilation, Supraglottic, Intranasal, Microlaryngeal Surgery
Brief summary
The key to a successful microlaryngoscopy is adequate operative field exposure and illumination. A variety of airway control procedures has been developed to improve operative exposure. A small size endotracheal tube is commonly used. However, some surgeon may suggest a 'no-tube' technique to optimize the surgical field. This study aims to investigate effectiveness and safety of a novel technique by supraglottic jet oxygenation and ventilation (SJOV) via nasal approach to facilitate optimal visualization in laser microlaryngeal surgery for small vocal polyps resection.
Detailed description
The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not possible to be blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation. The primary measurement is numerical rating scale (NRS) rated by surgeon according to surgical exposure and visualization. The secondary measurements are operation duration, and Intraoperative pulse oximetry (SpO2), PetCO2. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description.
Interventions
DEVICEWEI NASAL JET (WNJ)
Jet ventilation was achieved with WEI NASAL JET (WNJ) connected to a manual jet ventilator (Driving pressure: 40 psi, fraction of inspired oxygen: 100% O2, Respiratory rate: 25/min, I/E ratio: 40%)
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for laser laryngeal surgery under general anesthesia
Exclusion criteria
* Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal disease. Patients with anticipated difficult airway.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale (NRS) rated by surgeon | Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once. | The surgeons rated surgical exposure and visualization on a numerical rating scale (NRS), ranging from 0 to 10, with 0 defined as the best condition and 10 as the worst. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation duration | Immediately after surgery, the duration of the operation was recorded by the investigator. | Duration of the operation |
Countries
China
Contacts
Primary ContactHui Qiao, M.D. Ph.D.
Outcome results
None listed