Vocal PolypNIDPNCT04247412
Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE
An observational study of Vocal Polyp, run by RenJi Hospital at 1 site in China.
Trial summary
Laryngomicrosurgery requires deep paralysis and general anesthesia to finish the procedure. After the procedure, patients need a long time to recover. In the present study, with the support of the transnasal humidified rapid-insufflation ventilatory exchange, laryngomicrosurgery would be finished under nonintubated… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Vocal Polyp
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2020to Dec 2021
- Phase
- Observational
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young patients who will under elective polypectomy of unilateral vocal cord.
Who may be able to join
- elective polypectomy of unilateral vocal cord
- age between 18 to 40
- be able to communicate
- estimated operation time less than 15min
- ASA I-II
- Agree to sign written informed consent
Who cannot join
- pregnancy or breastfeeding women
- severe gastrointestinal reflex disease
- neuromuscular disease
- body mass index(BMI)>30
- predictable difficult airway.
- allergy to medicine would be used in the present study including propofol, remifentanil or sugammadex
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Diansan Su, +862168383702, diansansu@yahoo.com
About this study
Official title: Laryngomicrosurgery Under Nonintubated Deep Paralysis (NIDP) General Anesthesia Supported by Transnasal Humidified Rapid-insufflation Ventilatory Exchange: A Case Series Study
Laryngomicrosurgery requires deep paralysis and general anesthesia to finish the procedure. After the procedure, patients need a long time to recover. In the present study, with the support of the transnasal humidified rapid-insufflation ventilatory exchange, laryngomicrosurgery would be finished under nonintubated deep paralysis (NIDP) general anesthesia. In this case series study, the investigators will test the safety and feasibility of such a technique.
- Conditions
- Vocal Polyp
- Keywords
- Laryngomicrosurgery, Nonintubated deep paralysis, Transnasal Humidified Rapid-insufflation Ventilatory Exchange
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of laryngomicrosurgery
complete the surgery within 15min,nonintubated,remove the polyp entirely,recover completely after surgery, no major adverse event
Measured: From the day before surgery till 2 days after surgery or before discharge
Secondary outcomes (1)
Total days that participants stay in hospital
Measured: Through study completion, an average 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start20 Apr 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocal PolypStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247412
- Sponsor's protocol ID
- diansansu
- Acronym
- NIDP
- Status last verified
- Sep 2021
- First submitted
- 27 Jan 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fan Y, Chi X, Zhu D, Yin J, Liu Y, Su D. Non-intubated deep paralysis: a new anaesthesia strategy for vocal cord polypectomy. Perioper Med (Lond). 2023 Apr 19;12(1):12. doi: 10.1186/s13741-023-00301-7.
PubMed 37076883
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngomicrosurgery Under Nonintubated Deep Paralysis (NIDP) General Anesthesia Supported by Transnasal Humidified Rapid-insufflation Ventilatory Exchange: A Case Series Study
- ClinicalTrials.gov ID
- NCT04247412
- Acronym / sponsor ID
- NIDP / diansansu
- Conditions
- Vocal Polyp
- Keywords
- Laryngomicrosurgery, Nonintubated deep paralysis, Transnasal Humidified Rapid-insufflation Ventilatory Exchange
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jan 2020 (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.
Laryngomicrosurgery requires deep paralysis and general anesthesia to finish the procedure. After the procedure, patients need a long time to recover. In the present study, with the support of the transnasal humidified rapid-insufflation ventilatory exchange, laryngomicrosurgery would be finished under nonintubated deep paralysis (NIDP) general anesthesia. In this case series study, the investigators will test the safety and feasibility of such a technique.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young patients who will under elective polypectomy of unilateral vocal cord.
Key inclusion criteria (6 listed)
- elective polypectomy of unilateral vocal cord
- age between 18 to 40
- be able to communicate
- estimated operation time less than 15min
- ASA I-II
Key exclusion criteria (6 listed)
- pregnancy or breastfeeding women
- severe gastrointestinal reflex disease
- neuromuscular disease
- body mass index(BMI)>30
- predictable 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.
Primary outcome
Success rate of laryngomicrosurgery
Time frame: From the day before surgery till 2 days after surgery or before discharge
complete the surgery within 15min,nonintubated,remove the polyp entirely,recover completely after surgery, no major adverse event
1 secondary outcome
Total days that participants stay in hospital
Time frame: Through study completion, an average 2 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 37076883Fan Y, Chi X, Zhu D, Yin J, Liu Y, Su D. Non-intubated deep paralysis: a new anaesthesia strategy for vocal cord polypectomy. Perioper Med (Lond). 2023 Apr 19;12(1):12. doi: 10.1186/s13741-023-00301-7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Polyp, run by RenJi Hospital 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 6 inclusion and 6 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 14 Sep 2021. 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 Diansan su, Dr. (+86 18616514088, 184872238@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of laryngomicrosurgery (time frame: From the day before surgery till 2 days after surgery or before discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04247412, which also lists 1 linked publication.
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 14 Sep 2021.