Clinical Trial: Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients

Brief Summary: Monitoring and quantification of reflux events in high risk critically ill inpatients and lower risk general medical/surgical inpatients, with comparison to relevant clinical variables.

Detailed Summary: The investigators will conduct a pilot prospective cohort study of the incidence of reflux of gastric contents into the esophagus and the correlation with clinically evident aspiration events. The investigators will demonstrate that an esophageal multichannel pH/impedance probe can be used safely and effectively in an inpatient population to monitor reflux of acidic and non-acidic contents into the esophagus. The investigators will determine the frequency and severity of reflux events in a 24 hour period in two hospitalized patient populations: general medicine patients on the wards and critically ill patients in the intensive care unit. The investigators will then examine the relationship between the documented reflux events and clinically apparent aspiration events. The incidence of these silent reflux events in hospitalized patients is currently unclear.
Sponsor: Vanderbilt University

Current Primary Outcome: Number of reflux events [ Time Frame: 24 hours ]

Summation of acid reflux events and non-acid reflux events over 24hr monitoring period measured by pH change and impedance change detected by the probe


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinically apparent aspiration events [ Time Frame: Duration of hospitalization, on average 14 days ]
    Counting clinically apparent aspiration events by way of manual chart review
  • Combined aspiration event endpoint [ Time Frame: Duration of hospitalization, on average 14 days ]
    Summation of clinically apparent aspiration events, new infiltrates on chest imaging, increase in oxygen requirements, or need for higher level of care due to respiratory decompensation - all components determined by manual chart review


Original Secondary Outcome: Same as current

Information By: Vanderbilt University

Dates:
Date Received: March 14, 2016
Date Started: December 2016
Date Completion: April 2019
Last Updated: November 1, 2016
Last Verified: November 2016