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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: This study is designed to yield data on the intraoperative use of TaperGuard™endotracheal tubes and its potential influence on postoperative pulmonary complications and outcomes. The TaperGuard Basic tube has a taper-shaped cuff and has been shown, via bench and animal testing, to decrease microaspiration, which has been associated with respiratory difficulties. The intraoperative use of this tube (i.e. during short term intubation), and its impact on postoperative complications and outcomes has not been investigated. This study will determine whether the intraoperative use of the TaperGuard tube results in a decrease in microaspiration compared to the Hi-Lo endotracheal tube having a barrel-shaped cuff. Moreover, the relationship between a decrease in microaspiration and subsequent decrease in postoperative respiratory complications will be explored.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Hi-Lo endotracheal tube	Methylene Blue	Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
TaperGuard endotracheal tube	Methylene Blue	TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dye Leakage	Duration of surgical procedure - from 2 to 12 hours	Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	Time from discharge from PACU to discharge from hospital up to 72 hours	Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.
Number of Participants With Postoperative Pneumonia	Up to 30 days after surgery	Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery
Number of Participants With Unanticipated Intensive Care Unit Admission	Time from discharge from PACU to discharge from hospital up to 72 hours	Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.