SJOV With WNJ in Microlaryngeal Surgery
WNJ
Supraglottic Jet Oxygenation and Ventilation Via Nasal Approach During Laser Microlaryngeal Surgery for Vocal Polyps Resection
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedFebruary 15, 2019
February 1, 2019
3 months
February 11, 2019
February 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Operation duration
Immediately after surgery, the duration of the operation was recorded by the investigator.
Study Arms (2)
Group J
EXPERIMENTALJet ventilation was achieved via supraglottic jet oxygenation and ventilation with WEI NASAL JET (WNJ).
Group I
NO INTERVENTIONPatients were ventilated with a small size endotracheal tube.
Interventions
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%)
Eligibility Criteria
You may qualify if:
- Patients scheduled for laser laryngeal surgery under general anesthesia
You may not qualify if:
- Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal disease. Patients with anticipated difficult airway.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye, Ear, Nose and Throat Hospital
Shanghai, Shanghai Municipality, 200031, China
Study Officials
- STUDY DIRECTOR
Wenxian Li, M.D. Ph.D.
Eye and ENT Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Anesthesiologist
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 15, 2019
Study Start
January 1, 2019
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
February 15, 2019
Record last verified: 2019-02