Trial Outcomes & Findings for Improving Oral Care to Reduce Hospital-Acquired Pneumonia (HAP) in the Acute Neurologically Impaired Adult (NCT NCT01498601)

Results Overview

Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

10 months

Results posted on

2015-09-22

Participant Flow

The retrospective study group included care-dependent adults with a primary diagnosis of neurological injury/insult (n=51) meeting the inclusion criteria. Enrolled subjects in the prospective study received the experimental protocol (n=32).

Participant milestones

Participant milestones
Measure	Retrospective Study Group A retrospective chart review identified matched in-patients meeting the study inclusion criteria.	Oral Care Treatment Group All subjects in the intervention group received the enhanced oral care protocol: * Changing mouth suction equipment every 24 hours * Mouth assessment every 2-4 hours * Cleansing mouth with toothbrush every 12 hours * Cleansing oral mucosa with oral rinse solution every 2-4 hours * Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours * Suction mouth and throat as needed * Head of the bed elevated to a minimum of 30° during oral care
Overall Study STARTED	51	32
Overall Study COMPLETED	51	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Oral Care to Reduce Hospital-Acquired Pneumonia (HAP) in the Acute Neurologically Impaired Adult

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Care Treatment Group n=32 Participants Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified upon admission to the in-patient unit during the study period.	Retrospective Study Group n=51 Participants Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified through a retrospective chart review for the same in-patient unit.	Total n=83 Participants Total of all reporting groups
Age, Customized Age >=19	32 participants n=5 Participants	51 participants n=7 Participants	83 participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	24 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment Canada	32 participants n=5 Participants	51 participants n=7 Participants	83 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 months

Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.

Outcome measures

Outcome measures
Measure	Oral Care Treatment Group n=32 Participants Acute neurologically impaired adults receiving the study protocol	Retrospective Study Group n=51 Participants Acute neurologically impaired adults in the retrospective chart review
Hospital Acquired Pneumonia Occurrences	2 participants	13 participants

Adverse Events

Oral Care Treatment Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Retrospective Study Group

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Care Treatment Group n=32 participants at risk Subjects meeting the inclusion criteria and identified at the point of admission to the in-patient unit during the study period.	Retrospective Study Group n=51 participants at risk Subjects were identified through a chart review process for in-patients on the study unit unit during the retrospective study period and met the inclusion criteria .
Respiratory, thoracic and mediastinal disorders pneumonia	6.2% 2/32 • Number of events 2 • 6 months. Participants experience included total time receiving treatment up to and not exceeding 6 months.	25.5% 13/51 • Number of events 13 • 6 months. Participants experience included total time receiving treatment up to and not exceeding 6 months.

Other adverse events

Adverse event data not reported

Additional Information

Trudy Robertson RN, MSN, CNN(c)

Fraser Health

Phone: 604-520-4715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place