Back to resultsCan Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
Primary Purpose
Hospital Acquired Pneumonia in Gurgling Patients
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Anti-gurgling intervention
Sponsored by
About this trial
This is an interventional prevention trial for Hospital Acquired Pneumonia in Gurgling Patients
Eligibility Criteria
Inclusion Criteria:
- Gurglers who consent to participate
Exclusion Criteria:
- Non-gurglers
- Patients presenting with pneumonia prior to identification with gurgling
- Patients receiving comfort-care-only
Sites / Locations
Outcomes
Primary Outcome Measures
Hospital acquired pneumonia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01134133
Brief Title
Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
Official Title
Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Slow recruitment (preemptive treatment of gurglers, after association was published)
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bridgeport Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hospital inpatients who have gurgling sounds heard during speech or breathing have been observed to have a higher risk of hospital acquired pneumonia. Patients who gurgle and who consent to participation will be randomized to receive routine clinical management or management to include measures employed to reduce risks of aspiration, namely, 1. head of bed up (30 degrees or higher), 2. swallowing evaluation by speech therapist (and feeding predicated on formal evaluation), 3. prompting managing physicians to reduce sedating medications to minimal effective dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital Acquired Pneumonia in Gurgling Patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Anti-gurgling intervention
Intervention Description
1. head of bed 30 degrees or higher, 2. swallowing evaluation-based feeding, 3. sedatives titrated to minimal effective dose.
Primary Outcome Measure Information:
Title
Hospital acquired pneumonia
Time Frame
14 days (average)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gurglers who consent to participate
Exclusion Criteria:
Non-gurglers
Patients presenting with pneumonia prior to identification with gurgling
Patients receiving comfort-care-only
12. IPD Sharing Statement
Learn more about this trial
Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
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