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
1 other identifier
observational
48
1 country
1
Brief Summary
In this study, subjects meeting criteria will be enrolled and randomized to one of two different suctioning schemes, either continuous or intermittent. Accumulated secretions will be collected above the cuff on the breathing tube by one of the two methods depending on which group the subject is randomized into. Secretions will continue to be collected at predetermined periods of time for the duration of surgery in order to characterize the pH and volume as well as the micro-organism content.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedOctober 26, 2010
October 1, 2010
5 months
April 22, 2010
October 25, 2010
Conditions
Keywords
Study Arms (2)
Continuous Suctioning
Anesthesia staff will suction secretions continuously at 20 mmHg with a safety stop of 5 seconds every 30 minutes.
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.
Eligibility Criteria
Adults undergoing surgery requiring intubation using the TaperGuard EVAC Endotracehal Tube
You may qualify if:
- 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
You may not qualify if:
- Presence of tracheostomy
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (1)
Tulane University Hospital
New Orleans, Louisiana, 70112, United States
Biospecimen
Suction secretions
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis A Rosinia, M.D.
Tulane University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 26, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2010
Study Completion
October 1, 2010
Last Updated
October 26, 2010
Record last verified: 2010-10