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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01539135
First received: February 6, 2012
Last updated: May 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Respiratory Aspiration
Drug: Methylene Blue

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Endotracheal Tube Cuff Design on Intraoperative Microaspiration and Postoperative Respiratory Complications

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Microaspiration [ Time Frame: Duration of surgical procedure - from 2 to 12 hours ] [ Designated as safety issue: No ]
    Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The quantity of dye leakage past the endotracheal tube cuff will be measured via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Time from discharge from PACU to discharge from hospital up to 72 hours ] [ Designated as safety issue: No ]
    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.

  • Postoperative pneumonia [ Time Frame: Up to 30 days after surgery ] [ Designated as safety issue: No ]
    Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery

  • Unanticipated Intensive Care Unit admission (length of stay) [ Time Frame: Time from discharge from PACU to discharge from hospital up to 72 hours ] [ Designated as safety issue: No ]
    Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.


Enrollment: 80
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Methylene Blue
20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
Other Name: Methylene Blue Dye
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
Drug: Methylene Blue
20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
Other Name: Methylene Blue Dye

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539135

Locations
United States, Louisiana
Tulane University Hospital and Clinics
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Sabrina Bent, MD Tulane University
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01539135     History of Changes
Other Study ID Numbers: COVAIPR0235
Study First Received: February 6, 2012
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
Aspiration, Respiratory

Additional relevant MeSH terms:
Respiratory Aspiration
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014