Post Operative Sore ThroatNCT01305265
Post-operative Sore Throat as Determined by Endotracheal Tube Inflation Technique
A study testing cuff manometer in people with Post Operative Sore Throat and Dysphagia, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Sore Throat, Dysphagia, Hoarseness
- What is being tested?
- cuff manometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for general anesthesia requiring endotracheal intubation with planned duration of at least 2 hours
- ASA I-3
Who cannot join
- Planned prolonged intubation
- Planned postoperative ICU admission
- Non English speaking
- Mentally impaired
- Existing tracheal stoma
- Nasogastric tube in place preoperative
Show all 9Show fewer
- Thyroid / intra-oral surgery
- Previous general anesthesia within the last 2 weeks
- Use of steroids within one week before surgery (IV,inhaled, oral)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Post-operative Sore Throat as Determines by Endotracheal Tube Inflation Technique
The purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique.
The investigators hypothesis is that inflation of the endotracheal balloon using a cuff manometer immediately after intubation will reduce the incidence of sore throat and other tracheal co-morbidities.
- Conditions
- Post Operative Sore Throat, Dysphagia, Hoarseness
- Being tested
- cuff manometer
- Keywords
- sore throat, dysphagia, hoarseness, post operative, endotracheal intubation
- Medical subject headings
- Deglutition Disorders, Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuff manometerDevice
endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | Endotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer Receives: Device: cuff manometer |
| control | No intervention | endotracheal tube cuff will be inflated using standard technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Tracheopharyngeal Symptoms
Measured: within 2 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Operative Sore ThroatStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305265
- Sponsor's protocol ID
- weottp
- Status last verified
- Jan 2014
- First submitted
- 24 Feb 2011
- Last updated
- 26 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Sore Throat as Determines by Endotracheal Tube Inflation Technique
- ClinicalTrials.gov ID
- NCT01305265
- Acronym / sponsor ID
- weottp
- Conditions
- Post Operative Sore Throat, Dysphagia, Hoarseness
- Keywords
- sore throat, dysphagia, hoarseness, post operative, endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Posted 26 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique.
The investigators hypothesis is that inflation of the endotracheal balloon using a cuff manometer immediately after intubation will reduce the incidence of sore throat and other tracheal co-morbidities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Device: cuff manometerEndotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer |
| control | No intervention | –endotracheal tube cuff will be inflated using standard technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for general anesthesia requiring endotracheal intubation with planned duration of at least 2 hours
- ASA I-3
Key exclusion criteria (9 listed)
- Planned prolonged intubation
- Planned postoperative ICU admission
- Non English speaking
- Mentally impaired
- Existing tracheal stoma
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 |
|---|---|---|
| cuff manometerendotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer | Device | intervention |
Primary outcome
Incidence of Tracheopharyngeal Symptoms
Time frame: within 2 hours after extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cuff manometer in people with Post Operative Sore Throat and Dysphagia, run by University of California, San Francisco at 1 site in United States.
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 9 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 26 Feb 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Tracheopharyngeal Symptoms (time frame: within 2 hours after extubation). 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 26 Feb 2014.