Study Stopped
Slow recruitment (preemptive treatment of gurglers, after association was published)
Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2010
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJune 23, 2011
February 1, 2010
5 months
May 25, 2010
June 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital acquired pneumonia
14 days (average)
Interventions
1\. head of bed 30 degrees or higher, 2. swallowing evaluation-based feeding, 3. sedatives titrated to minimal effective dose.
Eligibility Criteria
You may qualify if:
- Gurglers who consent to participate
You may not qualify if:
- Non-gurglers
- Patients presenting with pneumonia prior to identification with gurgling
- Patients receiving comfort-care-only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 31, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
June 23, 2011
Record last verified: 2010-02