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We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cuffed ETT | Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cuffed ETT | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Intracuff Pressure | Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement. | during time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26956620 | Result | Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 Mar 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cuffed ETT | Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cuffed ETT | Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. Cuffed ETT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Changes in the Intracuff Pressure | Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement. | Posted | Mean | Standard Deviation | cmH2O | during time of surgery |
|
|
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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 | Cuffed ETT | Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kris Jatana, MD | Nationwide Children's Hospital | 614-722-6032 | Kris.Jatana@nationwidechildrens.org |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 84 |
| 0 |
| 84 |
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