View Clinical Trial (Medical Research Study)
The Influence of Endotracheal Tube Cuff Design on Intraoperative Microaspiration and Postoperative Respiratory Complications
| City: |
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New Orleans |
| State: |
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Louisiana |
| Zip Code: |
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70112 |
| Conditions: |
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Intraoperative Microaspiration |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01539135 |
| Primary Contact: |
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Johnathan M Deckert
Phone: 3033190840
Email: johnathan.deckert@covidien.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Orleans, Louisiana 70112
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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