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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Withdrawn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
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acid Aspiration Syndrome focused on measuring aspiration, reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    March 14, 2016
    Last Updated
    January 23, 2018
    Sponsor
    Vanderbilt University
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    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

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

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