- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01110109
Removing Fluid Above Breathing Tubes in the Operating Room
EVAC Use in the OR: A Randomized Clinical Study to Evaluate the Content of Fluid Extracted From the Endotracheal Tube Cuff Using Intermittent and Continuous Suctioning During Surgery
Study Overview
Status
Conditions
Detailed Description
The development of pneumonia and other infections from intubation in the intraoperative setting has not been well-studied. An understanding of the content of the fluid that accumulates above the cuff in this setting will further strengthen the relationship between intubation and infection. The purpose of this study is to characterize the content of fluid extracted from the endotracheal tube cuff during surgery. This study will also evaluate the content of the fluid across various intervals of suctioning.
Suctioning Schemes -
- Continuous Suctioning Anesthesia staff will suction secretions continuously at 20 mmHg with a safety stop of 5 seconds every 30 minutes. Staff will be responsible for monitoring the interval between each safety stop.
- Intermittent Suctioning Anesthesia staff will suction secretions intermittently using an intermittent suction regulator. The regulator will be set to suction at 100-150 mmHg. The regulator has a preset cycle of intermittent suctioning for 15 seconds with an 8 second pause.
This is a prospective randomized clinical study of 48 subjects at a single site in the United States. Those placing the tube and performing the suctioning schemes will be experienced study staff and have met all training requirements to ensure consistency. Subjects will be patients undergoing surgery requiring intubation using the TaperGuard Evac Endotracheal Tube for a minimum of two hours, but no longer than twelve hours. They must also be 18 years of age or older, able to provide consent and have no presence of tracheostomy. Pregnant subjects will also be excluded.
Suctioning will begin as soon as the tube is in place and will continue until extubation or until the patient is moved from the operating room, whichever comes earlier. Secretions will be collected in a Lukens Trap. Anesthesia staff will collect the accumulated secretions every 30 minutes for the duration of the surgery, and secretions will be processed according to the instructions provided in the sample collection kit.
To address the first objective of the study, the first and last sample obtained from each subject will be analyzed individually for pH, volume, and microorganisms; all other samples will be evaluated for volume. The amount of colony forming units (CFUs) will be determined semi-quantitatively across all organisms, and presented separately for individual genera and species. The samples will be characterized with descriptive statistics including frequencies, percentages, means, medians, standard deviations, and 95% CIs. To address the second objective of the study, comparisons of pH, volume, microorganisms, and CFUs by suctioning scheme and patient-level characteristics will be conducted using chi-squared tests of independence and analysis of variance (ANOVA). Graphical methods will be developed to aid interpretation, both as a function of time and cumulatively over time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Surgery to be performed with expected time between tracheal intubation and extubation of at least two hours, but no longer than 12 hours
- Intubation planned with TaperGuard EVAC Endotracheal Tube
- Age of 18 or older
- Ability to provide informed consent
Exclusion Criteria:
- Presence of tracheostomy
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Continuous Suctioning
Anesthesia staff will suction secretions continuously at 20 mmHg with a safety stop of 5 seconds every 30 minutes.
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Intermittent Suctioning
Anesthesia staff will suction secretions intermittently using an intermittent suction regulator.
The regulator will be set to suction at 100-150 mmHg.
The regulator has a preset cycle of intermittent suctioning for 15 seconds with an 8 second pause.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francis A Rosinia, M.D., Tulane University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COV-MO-PO-A111
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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