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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
  Purpose

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.


Condition Intervention
The Reduction of Aspiration Rate in Intubated Patients
 Other: Observation of fluid leakage around tracheal tube cuffs

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Tracheal Tube Size on Pulmonary Aspiration Different Endotracheal Tube Size Influences Pulmonary Aspiration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Aspiration rate [ Time Frame: during 5 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: February 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group ID 7.5
Patients with a tracheal tube ID (internal diameter) 7.5 mm
 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 8.0
Patients with a tracheal tube ID 8.0 mm
 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients,scheduled for elective cardiac surgery under general anesthesia

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058928

Contacts
Contact: Jin-Young Hwang, M.D. 82-16-746-4750 mistyblue15@naver.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

Publications:

Responsible Party: Jin-Young Hwang/ M.D., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01058928     History of Changes
Other Study ID Numbers: B-0912-090-012
Study First Received: January 28, 2010
Last Updated: January 28, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
Tracheal tube
Size

ClinicalTrials.gov processed this record on May 16, 2013