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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Active Comparator | Endotracheal 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cuff manometer | Device | endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Tracheopharyngeal Symptoms | within 2 hours after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Endotracheal tube cuff will be inflated using the inflate&palpate technique |
| FG001 | Intervention Group | Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Endotracheal tube cuff inflated using the inflate & palpate technique |
| BG001 | Intervention Group | Endotracheal tube cuff inflated using the inflate & palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Tracheopharyngeal Symptoms | Posted | Number | participants | within 2 hours after extubation |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Endotracheal tube cuff will be inflated using the inflate&palpate technique |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kolodzie, Kerstin M.D, PhD, Principal Investigator | Dept. of Anesthesia & Perioperative Care, UCSF San Francisco | 4158853647 | kolodziek@anesthesia.ucsf.edu |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D006685 | Hoarseness |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Intervention Group | Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff. | 0 | 64 | 0 | 64 |
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| D010038 | Otorhinolaryngologic Diseases |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009057 | Stomatognathic Diseases |