Complication of Artificial AirwayNCT02539485
Heating Precondition of Streamlined Liner of the Pharynx Airway Decrease the Incidence of Sore Throat
A study testing heating precondition in people with Complication of Artificial Airway, run by Fudan University at 1 site in China.
Trial summary
The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on respiratory mechanics and sore throat was investigated. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Complication of Artificial Airway
- What is being tested?
- heating precondition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Aug 2015
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hysteroscopic surgery
- General anesthesia
Who cannot join
- Upper respiratory disease
- Communication disfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Obstetric & Gynecology Hospital
Shanghai, Shanghai Municipality, 200090
Guiqi Geng, PhD, 86 21 33189900 ext. 6534, mzgengguiqi@163.com
About this study
The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on respiratory mechanics and sore throat was investigated.
- Conditions
- Complication of Artificial Airway
- Being tested
- heating precondition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heating preconditionOther
The streamlined liner of the pharynx airway (SLIPA) was heated 2 hours before use.
| Study group | Role | What they receive |
|---|---|---|
| heating precondition | Other | The mean maximum sealing pressure, gas leakage, gastric distension, postoperative sore throat and other complication were compared between heating precondition group and control group. Receives: Other: heating precondition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Measured: 5 minutes
postoperative sore throat
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
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 Complication of Artificial AirwayStudies of the same condition, open and under way.
- More trials run by 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geng guiqi, Fudan University
- Investigators
- Guiqi Geng, PhD, Principal investigator, obstetric & gynecology hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539485
- Sponsor's protocol ID
- 15381538
- Status last verified
- Aug 2015
- First submitted
- 28 Aug 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
Publications
Geng G, Chen Y, Liu H. Preheating of streamlined liner of pharyngeal airway (SLIPA) reduced the related complications: a randomized control study. J Clin Monit Comput. 2017 Jun;31(3):547-550. doi: 10.1007/s10877-016-9875-z. Epub 2016 Apr 8.
PubMed 27059218
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heating Precondition of Streamlined Liner of the Pharynx Airway Decrease the Incidence of Sore Throat
- ClinicalTrials.gov ID
- NCT02539485
- Acronym / sponsor ID
- 15381538
- Conditions
- Complication of Artificial Airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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 effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on respiratory mechanics and sore throat was investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heating precondition | Other | Other: heating preconditionThe mean maximum sealing pressure, gas leakage, gastric distension, postoperative sore throat and other complication were compared between heating precondition group and control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hysteroscopic surgery
- General anesthesia
Key exclusion criteria (2 listed)
- Upper respiratory disease
- Communication disfunction
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 |
|---|---|---|
| heating preconditionThe streamlined liner of the pharynx airway (SLIPA) was heated 2 hours before use. | Other | heating precondition |
Primary outcome
Oropharyngeal leak pressure
Time frame: 5 minutes
postoperative sore throat
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- Derived from this study: PubMed 27059218Geng G, Chen Y, Liu H. Preheating of streamlined liner of pharyngeal airway (SLIPA) reduced the related complications: a randomized control study. J Clin Monit Comput. 2017 Jun;31(3):547-550. doi: 10.1007/s10877-016-9875-z. Epub 2016 Apr 8.
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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.
Guiqi Geng, PhD principal investigator
obstetric & gynecology hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heating precondition in people with Complication of Artificial Airway, run by 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 2 inclusion and 2 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 3 Sep 2015. 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 Guiqi mi Geng, PhD (86 21 33189900 ext. 6868, mzgengguiqi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal leak pressure (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 NCT02539485, 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 3 Sep 2015.