The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery

Completed · Not applicable

Conditions studied: Respiratory Aspiration

In brief

Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been shown in animals to decrease the leakage of fluid past the cuff better than a traditional tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study will investigate whether the use of the TaperGuard tube is associated with a decrease in respiratory complications often seen following surgery which may be related to fluid leaking past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal tube will result in a decrease in fluid leakage past the cuff and that it will be associated with a decrease in respiratory complications during the 30 days after surgery.

Key facts

Study ID

NCT01539135

Run by

Medtronic - MITG

People needed

80

Starts

2012-04-01

Expected to finish

2013-05-01

Last updated by the study team

2015-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female of all races
• Older than 18 years old
• Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route
• Willing and able to give informed consent for participation in the study
• Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU
• Expected hospital stay of greater than or equal to 23hrs

You may not qualify if…

• Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery
• Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery
• Surgical requirement for naso-tracheal intubation
• Patients undergoing surgical procedures directly on the lungs, trachea, or airways
• Presence of tracheostomy
• History of allergic reaction to methylene blue
• Methemoglobinemia, glucose-6-phosphate (G6PD) deficiency
• Renal insufficiency or failure
• Requirement for prolonged intubation and/or ventilation beyond the point of PACU admission
• Intraoperative use of nitrous oxide, to avoid the increase in cuff pressure due to diffusion of gas over time
• Psychiatric drugs of the following classifications: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).
• Patients younger than 18 years of age
• Prone positioning during surgery
• Pregnant or lactating women based on standardized preoperative screening protocols
• Legally detained prisoner status
• Unwilling or unable to give informed consent for participation in the study

Where it is running

• Tulane University Hospital and Clinics — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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