SJOV With WNJ in Microlaryngeal Surgery

Other Complications of Surgical and Medical Procedures Clinical Trial

— WNJ  

Official title:

Supraglottic Jet Oxygenation and Ventilation Via Nasal Approach During Laser Microlaryngeal Surgery for Vocal Polyps Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03840876
• Other study ID #: WNJ
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 1, 2019

Study information

• Verified date: February 2019
• Source: Eye & ENT Hospital of Fudan University
• Contact: Hui Qiao, M.D. Ph.D.
• Phone: 8615900598163
• Email: theyellow[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Other Complications of Surgical and Medical Procedures

Intervention

Device:
• WEI 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%)

Locations

Country	Name	City	State
China	Eye, Ear, Nose and Throat Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating scale (NRS) rated by surgeon	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.	Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once.
Secondary	Operation duration	Duration of the operation	Immediately after surgery, the duration of the operation was recorded by the investigator.