Effects of Tracheal Tube Size on Pulmonary Aspiration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Seoul National University Bundang Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01058928
First received: January 28, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted

January 28, 2010
January 28, 2010
February 2010
August 2010   (final data collection date for primary outcome measure)
Aspiration rate [ Time Frame: during 5 hours ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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Effects of Tracheal Tube Size on Pulmonary Aspiration
Effects of Tracheal Tube Size on Pulmonary Aspiration Different Endotracheal Tube Size Influences Pulmonary Aspiration

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients,scheduled for elective cardiac surgery under general anesthesia

The Reduction of Aspiration Rate in Intubated Patients
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.
  • Group ID 7.5
    Patients with a tracheal tube ID (internal diameter) 7.5 mm
    Intervention: Other: Observation of fluid leakage around tracheal tube cuffs
  • Group ID 8.0
    Patients with a tracheal tube ID 8.0 mm
    Intervention: Other: Observation of fluid leakage around tracheal tube cuffs

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
36
October 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients, aged 20-65 yr scheduled for elective cardiac surgery under general anesthesia

Exclusion Criteria:

  • Patients with an upper airway and vocal cord disease, pneumonia before surgery, a history of tracheostomy and tracheal stenosis.
Male
20 Years to 65 Years
No
Contact: Jin-Young Hwang, M.D. 82-16-746-4750 mistyblue15@naver.com
Korea, Republic of
 
NCT01058928
B-0912-090-012
Yes
Jin-Young Hwang/ M.D., Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
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Not Provided
Seoul National University Bundang Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP