An interventional study of cuff manometer in Post Operative Sore Throat, Dysphagia and Hoarseness, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-26.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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.
252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.
This study's enrollment of 141 is close to the median of 144 across 209 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Endotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer
Device: cuff manometer
endotracheal tube cuff will be inflated using standard technique
endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer
Incidence of Tracheopharyngeal Symptoms
Time frame: within 2 hours after extubation
| Milestone | Control Group | Intervention Group |
|---|---|---|
| Started | 71 | 70 |
| Completed | 69 | 64 |
| Not completed | 2 | 6 |
| participants | Control Group | Intervention Group |
|---|---|---|
| Incidence of Tracheopharyngeal Symptoms | 53 | 49 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/69 (0%) | 0/69 (0%) |
| Intervention Group | — | 0/64 (0%) | 0/64 (0%) |
| Age, Continuous(years) | Control Group | Intervention Group | Total |
|---|---|---|---|
| Mean | 52.4 ± 15.8 | 50.3 ± 13.8 | 51.4 ± 14.9 |
| Sex: Female, Male(Participants) | Control Group | Intervention Group | Total |
|---|---|---|---|
| Female | 32 | 34 | 66 |
| Male | 37 | 30 | 67 |
| Region of Enrollment(participants) | Control Group | Intervention Group | Total |
|---|---|---|---|
| United States | 69 | 64 | 133 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco