Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?

June 21, 2011 updated by: Bridgeport Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Hospital Acquired Pneumonia in Gurgling Patients

Intervention / Treatment

Other: Anti-gurgling intervention

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital acquired pneumonia Time Frame: 14 days (average)	14 days (average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bridgeport Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimate)

May 31, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified