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Removing Fluid Above Breathing Tubes in the Operating Room

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ClinicalTrials.gov Identifier: NCT01110109
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : October 26, 2010
Sponsor:
Information provided by:
Medtronic - MITG

Tracking Information
First Submitted Date April 22, 2010
First Posted Date April 26, 2010
Last Update Posted Date October 26, 2010
Study Start Date April 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01110109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Removing Fluid Above Breathing Tubes in the Operating Room
Official Title 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
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.
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 Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Suction secretions
Sampling Method Probability Sample
Study Population Adults undergoing surgery requiring intubation using the TaperGuard EVAC Endotracehal Tube
Condition Pneumonia, Ventilator-Associated
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April¬†23,¬†2010)
48
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01110109
Other Study ID Numbers COV-MO-PO-A111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jonathan Bissett/Clinical Research Associate II, Covidien
Study Sponsor Medtronic - MITG
Collaborators Not Provided
Investigators
Principal Investigator: Francis A Rosinia, M.D. Tulane University Hospital
PRS Account Medtronic - MITG
Verification Date October 2010