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

Acid Aspiration Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02720029
• Other study ID #: 141751
• Status: Withdrawn
• Phase: N/A
• First received: March 14, 2016
• Last updated: January 23, 2018
• Start date: December 2016
• Est. completion date: April 2019

Study information

• Verified date: January 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than 18 years

2. Admitted to medical-surgical floor or medical intensive care unit

Exclusion Criteria:

1. Patients with contraindication to nasogastric tube placement (facial trauma, active epistaxis, abnormal nasopharyngeal or facial anatomy, esophageal stricture or injury, esophageal varices)

2. Patients requiring non-invasive positive pressure ventilation

3. Patients with uncontrolled vomiting

4. Patients with planned or anticipated airway or esophageal procedure within the 24-hour monitoring period

5. Patients not expected to survive for 24 hours or those receiving hospice/palliative care

Related Conditions & MeSH terms

• Acid Aspiration Syndrome
• Pneumonia, Aspiration

Intervention

Device:
• pH/impedance monitor
Placement of pH/impedance monitor via the nasogastric route with monitoring for 24 hours, followed by removal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of reflux events	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	24 hours
Secondary	Clinically apparent aspiration events	Counting clinically apparent aspiration events by way of manual chart review	Duration of hospitalization, on average 14 days
Secondary	Combined aspiration event endpoint	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	Duration of hospitalization, on average 14 days