Other Complications of Surgical and Medical ProceduresWNJNCT03840876
SJOV With WNJ in Microlaryngeal Surgery
A study testing WEI NASAL JET (WNJ) in people with Other Complications of Surgical and Medical Procedures, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Other Complications of Surgical and Medical Procedures
- What is being tested?
- WEI NASAL JET (WNJ)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for laser laryngeal surgery under general anesthesia
Who cannot join
- Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal disease. Patients with anticipated difficult airway.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye, Ear, Nose and Throat Hospital
Shanghai, Shanghai Municipality, 200031
Hui Qiao, Doctor, 021-64377134, qiaohui@eentanesthesia.com
About this study
Official title: Supraglottic Jet Oxygenation and Ventilation Via Nasal Approach During Laser Microlaryngeal Surgery for Vocal Polyps Resection
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.
Read the 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.
- Being tested
- WEI NASAL JET (WNJ)
- Keywords
- Jet Ventilation, Supraglottic, Intranasal, Microlaryngeal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEI NASAL JET (WNJ)Device
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%)
| Study group | Role | What they receive |
|---|---|---|
| Group J | Experimental | Jet ventilation was achieved via supraglottic jet oxygenation and ventilation with WEI NASAL JET (WNJ). Receives: Device: WEI NASAL JET (WNJ) |
| Group I | No intervention | Patients were ventilated with a small size endotracheal tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once.
Secondary outcomes (1)
Operation duration
Duration of the operation
Measured: Immediately after surgery, the duration of the operation was recorded by the investigator.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2019
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Complications of Surgical and Medical ProceduresStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Qiao, Eye & ENT Hospital of Fudan University
- Investigators
- Wenxian Li, M.D. Ph.D., Study director, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840876
- Sponsor's protocol ID
- WNJ
- Acronym
- WNJ
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraglottic Jet Oxygenation and Ventilation Via Nasal Approach During Laser Microlaryngeal Surgery for Vocal Polyps Resection
- ClinicalTrials.gov ID
- NCT03840876
- Acronym / sponsor ID
- WNJ / WNJ
- Keywords
- Jet Ventilation, Supraglottic, Intranasal, Microlaryngeal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group J | Experimental | Device: WEI NASAL JET (WNJ)Jet ventilation was achieved via supraglottic jet oxygenation and ventilation with WEI NASAL JET (WNJ). |
| Group I | No intervention | –Patients were ventilated with a small size endotracheal tube. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled for laser laryngeal surgery under general anesthesia
Key exclusion criteria (1 listed)
- Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal disease. Patients with anticipated difficult airway.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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%) | Device | Group J |
Primary outcome
Numerical rating scale (NRS) rated by surgeon
Time frame: 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.
1 secondary outcome
Operation duration
Time frame: Immediately after surgery, the duration of the operation was recorded by the investigator.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenxian Li, M.D. Ph.D. study director
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEI NASAL JET (WNJ) in people with Other Complications of Surgical and Medical Procedures, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Qiao, M.D. Ph.D. (8615900598163, theyellow@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) rated by surgeon (time frame: Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.