NCT02720029

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Acid Aspiration Syndrome

Interventions

Type	Name	Description
DEVICE	pH/impedance monitor	Placement of pH/impedance monitor via the nasogastric route with monitoring for 24 hours, followed by removal.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-03-25
• Last updated: 2018-01-25