Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?

Hospital Acquired Pneumonia in Gurgling Patients Clinical Trial

Official title:

Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01134133
• Other study ID #: Gurgle
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 25, 2010
• Last updated: June 21, 2011
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: February 2010
• Source: Bridgeport Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 50
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hospital Acquired Pneumonia in Gurgling Patients
• Pneumonia

Intervention

Other:
• Anti-gurgling intervention
1. head of bed 30 degrees or higher, 2. swallowing evaluation-based feeding, 3. sedatives titrated to minimal effective dose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bridgeport Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital acquired pneumonia		14 days (average)	Yes