- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539135
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
August 5, 2015 updated by: Medtronic - MITG
The Influence of Endotracheal Tube Cuff Design on Intraoperative Microaspiration and Postoperative Respiratory Complications
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University Hospital and Clinics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hi-Lo endotracheal tube
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
|
20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
Other Names:
|
Experimental: TaperGuard endotracheal tube
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
|
20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Dye Leakage
Time Frame: 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.
|
Duration of surgical procedure - from 2 to 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of Hospital Stay
Time Frame: 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.
|
Time from discharge from PACU to discharge from hospital up to 72 hours
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Number of Participants With Postoperative Pneumonia
Time Frame: Up to 30 days after surgery
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Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery
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Up to 30 days after surgery
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Number of Participants With Unanticipated Intensive Care Unit Admission
Time Frame: Time from discharge from PACU to discharge from hospital up to 72 hours
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Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.
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Time from discharge from PACU to discharge from hospital up to 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sabrina Bent, MD, Tulane University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
February 6, 2012
First Submitted That Met QC Criteria
February 21, 2012
First Posted (Estimate)
February 27, 2012
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVAIPR0235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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