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To date, there are no data in the literature regarding changes in the intracuff pressure during prolonged surgical procedures. It is possible that the pressure will increase over time related to gas expansion during equilibration to body temperature. If this is the case, these patients may be at risk for tracheal damage. This is a prospective study to evaluate the changes in intracuff pressure over time during prolonged surgical procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac patients | Patients undergoing cardiac surgery |
| |
| Non-cardiac patients | Patients undergoing any surgery other than cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cuff pressure | Other | Measuring endotracheal tube (ETT) cuff pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intracuff Pressure | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing surgery lasting longer than 4 hours.
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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 |
|---|---|---|---|
| 25735902 | Derived | Kako H, Alkhatib O, Krishna SG, Khan S, Naguib A, Tobias JD. Changes in intracuff pressure of a cuffed endotracheal tube during surgery for congenital heart disease using cardiopulmonary bypass. Paediatr Anaesth. 2015 Jul;25(7):705-10. doi: 10.1111/pan.12631. Epub 2015 Mar 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Patients | Patients undergoing cardiac surgery Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure |
| FG001 | Non-cardiac Patients | Patients undergoing any surgery other than cardiac surgery Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Patients | Patients undergoing cardiac surgery Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure |
| BG001 | Non-cardiac Patients | Patients undergoing any surgery other than cardiac surgery Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure |
| 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 | Change in Intracuff Pressure | Posted | Mean | Standard Deviation | cmH2O | 1 day |
|
|
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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 | Cardiac Patients | Patients undergoing cardiac surgery Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senthil Krishna, MD | Nationwide Children's Hospital | 614-722-4200 | Senthil.Krishna@nationwidechildrens.org |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Non-cardiac Patients | Patients undergoing any surgery other than cardiac surgery Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure | 0 | 30 | 0 | 30 |
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