Effects of Tracheal Tube Size on Pulmonary Aspiration
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 28, 2010 | ||||
| Last Updated Date | January 28, 2010 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Aspiration rate [ Time Frame: during 5 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Tracheal Tube Size on Pulmonary Aspiration | ||||
| Official Title ICMJE | Effects of Tracheal Tube Size on Pulmonary Aspiration Different Endotracheal Tube Size Influences Pulmonary Aspiration | ||||
| Brief Summary | Fluid leak around the cuff is minimized when the endotracheal tube size is small relative to the size of the trachea. In the current study, the investigators assess the influence of different HVLP endotracheal tube size on fluid leakage around the cuff in a benchtop model and in anesthetized patients. |
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| Detailed Description | The use of a high-volume and low-pressure (HVLP) endotracheal cuff has reduced the cuff-induced tracheal damage because the cuff conforms passively to tracheal contours as it expands during inflation and the cuff inflation pressure is assumed to be equal to cuff-to-trachea pressure. However, longitudinal folds of a HVLP cuff occur on inflation within the trachea, as the diameter of the cuff is greater than that of the trachea, and these folds provide channels for an aspiration or gas leakage. Silent aspiration of upper airway secretions has been reported in patients undergoing general anesthesia and in the intensive care unit (ICU). A previous study reported the 83% aspiration of subglottic dye detected by bronchoscopy in anesthetized patients, and other study of intubated patients with HVLP cuffs in the ICU showed 87% aspiration rate. Intubation-related (ventilator associated pneumonia) pneumonia is a leading cause of prolongation of hospital stay, mortality and morbidity during the postoperative period and in the ICU. Therefore, it is important to achieve a better seal around the cuff without tracheal damage, which would reduce the incidence of pneumonia in intubated patients. A previous benchtop study demonstrated that the leak around the cuff is minimized when the endotracheal tube size is small relative to the size of the trachea. In the current study, we assess the influence of different HVLP endotracheal tube size on fluid leakage around the cuff in a benchtop model and in anesthetized patients. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients,scheduled for elective cardiac surgery under general anesthesia |
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| Condition ICMJE | The Reduction of Aspiration Rate in Intubated Patients | ||||
| Intervention ICMJE | Other: Observation of fluid leakage around tracheal tube cuffs
One milliliter of Evans blue diluted in 3.5 mL of saline solution is carefully instilled on the top of the tracheal tube cuff. In the operating room, one hour and five hours after intubation, fiberoptic bronchoscopy was performed to detect the possible presence of blue dye in the trachea. If a blue spot was seen on the trachea caudal to the tube's tip on any occasion, leakage was confirmed and the experiment was finished. |
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| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 36 | ||||
| Estimated Completion Date | October 2010 | ||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 20 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01058928 | ||||
| Other Study ID Numbers ICMJE | B-0912-090-012 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jin-Young Hwang/ M.D., Seoul National University Bundang Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Bundang Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Seoul National University Bundang Hospital | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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