Effects of Tracheal Tube Size on Pulmonary Aspiration

The Reduction of Aspiration Rate in Intubated Patients Clinical Trial

Official title:

Effects of Tracheal Tube Size on Pulmonary Aspiration Different Endotracheal Tube Size Influences Pulmonary Aspiration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01058928
• Other study ID #: B-0912-090-012
• Status: Not yet recruiting
• Phase: N/A
• First received: January 28, 2010
• Last updated: January 28, 2010
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2009
• Source: Seoul National University Bundang Hospital
• Contact: Jin-Young Hwang, M.D.
• Phone: 82-16-746-4750
• Email: mistyblue15[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• The Reduction of Aspiration Rate in Intubated Patients

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Blunt MC, Young PJ, Patil A, Haddock A. Gel lubrication of the tracheal tube cuff reduces pulmonary aspiration. Anesthesiology. 2001 Aug;95(2):377-81. — View Citation

Pavlin EG, VanNimwegan D, Hornbein TF. Failure of a high-compliance low-pressure cuff to prevent aspiration. Anesthesiology. 1975 Feb;42(2):216-9. — View Citation

Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspiration rate		during 5 hours	Yes