NCT04347395|Completed
Respiratory Infection in Older Patients
Prevention of Respiratory Infections in Older Patients During and After Hospitalisation: A Randomised Controlled Trial
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Prevention of Respiratory Infections in Older Patients During and After Hospitalisation: A Randomised Controlled Trial
Sponsor study identifier
interventional
123
1 country
1
Study Start
January 29, 2016
Actual (reported)Primary Completion
July 9, 2020
Actual (reported)Study Completion
July 14, 2020
Actual (reported)This randomized controlled trial in older hospitalized patients found that a respiratory care bundle intervention did not significantly reduce the incidence of respiratory infections compared to usual care for the index admission. However, time to next admission for respiratory infection was significantly longer with the intervention compared to usual care. Aim: To evaluate whether a respiratory care bundle, compared to usual care, reduces respiratory infections during and after hospitalization. Methods: In this open-label, single-centre randomized controlled trial, we recruited patients \>65 years of age and admitted \<72 hours for non-respiratory conditions to a novel respiratory care bundle intervention (whole bed tilt, swallow screen, chlorhexidine mouth wash, and pneumococcal and influenza vaccinations) or usual care. Participants were followed up for 12 months. The primary endpoint was the development of respiratory infection during the index admission. The secondary endpoint was the time to next admission for respiratory infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 14, 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 29, 2016
Actual (reported)April 14, 2020
Actual (reported)April 15, 2020
Actual (reported)July 9, 2020
Actual (reported)July 14, 2020
Actual (reported)In Older Patients (>65 years age)
To reduce the incidence of HAP
9.5months
In Older Patients (>65 years age)
9.5months
Current best practice for prevention of HAP
Respiratory Bundle Intervention
The respiratory care bundle intervention comprised of: bed tilt, swallow screen, mouth wash and vaccinations. The bed tilt was a 30-degree whole bed-up positioning both day and night throughout the hospital stay and is shown in Figure 1. Swallow screen was undertaken within 48 hours of admission. Chlorhexidine mouth wash was prescribed initially four times daily. The protocol was amended to twice daily chlorhexidine mouth wash in August 2017 due to poor compliance with four times daily administration. Mouthwash administration was monitored in the intervention group only and deemed non-compliant if missed more than 3 times during the admission. Pneumococcal and influenza vaccination was offered at discharge or within 2-4 weeks post discharge, at no charge to the patient. Post discharge advice was to use pillows in bed to minimize the time the patient laid flat and to avoid lying down for an hour after meals.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Changi General Hospital
Singapore, 529889, Singapore
Rosario BH, Shafi H, Yii ACA, Tee LY, Ang ASH, Png GK, Ang WST, Lee YQ, Tan PT, Sahu A, Zhou LF, Zheng YL, Slamat RB, Taha AAM. Evaluation of multi-component interventions for prevention of nosocomial pneumonia in older adults: a randomized, controlled trial. Eur Geriatr Med. 2021 Oct;12(5):1045-1055. doi: 10.1007/s41999-021-00506-3. Epub 2021 Jun 3.
123 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2020
First Posted
April 15, 2020
Study Start
January 29, 2016
Actual (reported)Physiotherapy on Pneumonia in Childrens
Contact the study team to confirm eligibility.
Primary Completion
July 9, 2020
Actual (reported)Study Completion
July 14, 2020
Actual (reported)Last Updated
October 8, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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