Acid Aspiration SyndromeNCT02720029
Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
A study testing pH/impedance monitor in people with Acid Aspiration Syndrome, run by Vanderbilt University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acid Aspiration Syndrome
- What is being tested?
- pH/impedance monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Admitted to medical-surgical floor or medical intensive care unit
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- pH/impedance monitor
- Keywords
- aspiration, reflux
- Medical subject headings
- Pneumonia, Aspiration, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH/impedance monitorDevice
Placement of pH/impedance monitor via the nasogastric route with monitoring for 24 hours, followed by removal.
| Study group | Role | What they receive |
|---|---|---|
| pH/impedance monitor | Experimental | Not described Receives: Device: pH/impedance monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (2)
Clinically apparent aspiration events
Counting clinically apparent aspiration events by way of manual chart review
Measured: Duration of hospitalization, on average 14 days
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
Measured: Duration of hospitalization, on average 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startDec 2016 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: Difficulty with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid Aspiration SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Fessel, Vanderbilt University
- Investigators
- Joshua P Fessel, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720029
- Sponsor's protocol ID
- 141751
- Status last verified
- Jan 2018
- First submitted
- 14 Mar 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT02720029
- Acronym / sponsor ID
- 141751
- Conditions
- Acid Aspiration Syndrome
- Keywords
- aspiration, reflux
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2016 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pH/impedance monitor | Experimental | Device: pH/impedance monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 18 years
- Admitted to medical-surgical floor or medical intensive care unit
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pH/impedance monitorPlacement of pH/impedance monitor via the nasogastric route with monitoring for 24 hours, followed by removal. | Device | pH/impedance monitor |
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
2 secondary outcomes
Clinically apparent aspiration events
Time frame: Duration of hospitalization, on average 14 days
Combined aspiration event endpoint
Time frame: Duration of hospitalization, on average 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua P Fessel, MD, PhD principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing pH/impedance monitor in people with Acid Aspiration Syndrome, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reflux events (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.