Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
Primary Purpose
Acid Aspiration Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pH/impedance monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for Acid Aspiration Syndrome focused on measuring aspiration, reflux
Eligibility Criteria
Inclusion Criteria:
- Age greater than 18 years
- Admitted to medical-surgical floor or medical intensive care unit
Exclusion Criteria:
- Patients with contraindication to nasogastric tube placement (facial trauma, active epistaxis, abnormal nasopharyngeal or facial anatomy, esophageal stricture or injury, esophageal varices)
- Patients requiring non-invasive positive pressure ventilation
- Patients with uncontrolled vomiting
- Patients with planned or anticipated airway or esophageal procedure within the 24-hour monitoring period
- Patients not expected to survive for 24 hours or those receiving hospice/palliative care
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pH/impedance monitor
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Clinically apparent aspiration events
Counting clinically apparent aspiration events by way of manual chart review
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02720029
Brief Title
Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
Official Title
Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty with enrollment
Study Start Date
December 2016 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acid Aspiration Syndrome
Keywords
aspiration, reflux
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pH/impedance monitor
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
pH/impedance monitor
Intervention Description
Placement of pH/impedance monitor via the nasogastric route with monitoring for 24 hours, followed by removal.
Primary Outcome Measure Information:
Title
Number of reflux events
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Clinically apparent aspiration events
Description
Counting clinically apparent aspiration events by way of manual chart review
Time Frame
Duration of hospitalization, on average 14 days
Title
Combined aspiration event endpoint
Description
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
Time Frame
Duration of hospitalization, on average 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater than 18 years
Admitted to medical-surgical floor or medical intensive care unit
Exclusion Criteria:
Patients with contraindication to nasogastric tube placement (facial trauma, active epistaxis, abnormal nasopharyngeal or facial anatomy, esophageal stricture or injury, esophageal varices)
Patients requiring non-invasive positive pressure ventilation
Patients with uncontrolled vomiting
Patients with planned or anticipated airway or esophageal procedure within the 24-hour monitoring period
Patients not expected to survive for 24 hours or those receiving hospice/palliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua P Fessel, MD, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
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