ArthroscopyNCT02184702
Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy
An observational study of Arthroscopy, run by Inje University at 1 site in South Korea.
Trial summary
Intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure cuff pressure during shoulder arthroscope. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Arthroscopy
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Jul 2016
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patints who undergoing shoulder arthroscopy American Society of Anesthesiologists (ASA) 1,2
Who may be able to join
- American Society of Anesthesiologists (ASA) 1,2 Age 20-65
Who cannot join
- emergency operation anticipated difficult intubation chronic obstructive lung disease recent upper respiratory infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Seoul Paik Hospital, Seoul, Korea
Seoul, Jung-Gu, 100-032
About this study
Intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure cuff pressure during shoulder arthroscope.
- Conditions
- Arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| shoulder arthroscopy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct intracuff pressure measurement technique using manometer
Measured: every one hour during operarion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroscopyStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi Korea
- Responsible party
- Principal investigator, Sira Bang, Inje University
- Investigators
- Sira Bang, MD, PhD, Principal investigator, Inje University Seoul Paik Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184702
- Sponsor's protocol ID
- IIT-2014-192
- Status last verified
- Aug 2016
- First submitted
- 3 Jul 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT02184702
- Acronym / sponsor ID
- IIT-2014-192
- Conditions
- Arthroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Fresenius Kabi Korea
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Jul 2014 (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.
Intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure cuff pressure during shoulder arthroscope.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder arthroscopy | – | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patints who undergoing shoulder arthroscopy American Society of Anesthesiologists (ASA) 1,2
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) 1,2 Age 20-65
Key exclusion criteria (1 listed)
- emergency operation anticipated difficult intubation chronic obstructive lung disease recent upper respiratory infection
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
Direct intracuff pressure measurement technique using manometer
Time frame: every one hour during operarion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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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.
Sira Bang, MD, PhD principal investigator
Inje University Seoul Paik Hospital, Seoul, Korea
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 Arthroscopy, run by Inje University at 1 site in South Korea.
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: finished, as of the sponsor's last update on 31 Aug 2016. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct intracuff pressure measurement technique using manometer (time frame: every one hour during operarion). 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 31 Aug 2016.