Postoperative SorethroatNCT01459354
The Effects of Bimanual Laryngoscopy on Post-Operative Sore Throat in Adults
An observational study of Postoperative Sorethroat and Bimanual Laryngoscopy, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable, distressing sequelae after tracheal intubation. It was postulated that these effects are because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to improve visual field during intubation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Sorethroat, Bimanual Laryngoscopy
- How many people
- 490 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to not given
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20-70 yrs patient receive elective surgery with general anesthesia without position change or any influence on sorethroat
Who may be able to join
- ASA I or II
- 20-70 y/o
- GAET for A. Breast op B. GYN op C. Upper/lower extremities op D. Ophthalmology op E. GU op F. minor surgery
Who cannot join
- emergency surgery
- head and neck surgery
- recent URI symptom in last one weeks with medication
- post op PCA use
- on NG/OG
- perioperative bucking
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Taiwan ROC, 40447
Chen kuen bao, master, 886-4-22052121-1925 or 1926, u702115@hotmail.com
About this study
Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable, distressing sequelae after tracheal intubation. It was postulated that these effects are because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to improve visual field during intubation. This procedure might reduce laryngeal trauma during intubation and therefore reduce the incidence or degree of post-operative sore throat. This is the first prospective, double-blinded, controlled study, which is focused on the effects of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).
- Conditions
- Postoperative Sorethroat, Bimanual Laryngoscopy
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 |
|---|---|---|
| post, bimanual laryngoscopy, POGO score | one control, one study group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative SorethroatStudies of the same condition, open and under way.
- More trials run by China Medical University 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-control
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459354
- Sponsor's protocol ID
- DMR100-IRB-146
- Status last verified
- Oct 2011
- First submitted
- 23 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bimanual Laryngoscopy on Post-Operative Sore Throat in Adults
- ClinicalTrials.gov ID
- NCT01459354
- Acronym / sponsor ID
- DMR100-IRB-146
- Conditions
- Postoperative Sorethroat, Bimanual Laryngoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- First posted
- 25 Oct 2011 (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.
Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable, distressing sequelae after tracheal intubation. It was postulated that these effects are because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to improve visual field during intubation. This procedure might reduce laryngeal trauma during intubation and therefore reduce the incidence or degree of post-operative sore throat. This is the first prospective, double-blinded, controlled study, which is focused on the effects of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post, bimanual laryngoscopy, POGO score | – | –one control, one study group |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20-70 yrs patient receive elective surgery with general anesthesia without position change or any influence on sorethroat
Key inclusion criteria (3 listed)
- ASA I or II
- 20-70 y/o
- GAET for A. Breast op B. GYN op C. Upper/lower extremities op D. Ophthalmology op E. GU op F. minor surgery
Key exclusion criteria (6 listed)
- emergency surgery
- head and neck surgery
- recent URI symptom in last one weeks with medication
- post op PCA use
- on NG/OG
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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 Postoperative Sorethroat and Bimanual Laryngoscopy, run by China Medical University Hospital at 1 site in Taiwan.
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 3 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 25 Oct 2011. 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 Taiwan. 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 Chen Kuen Bao, master (886-4-22052121-1925 or 1926, u702115@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 25 Oct 2011.