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Respiratory Infection in Older Patients

NCT04347395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2020-10-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Respiratory Bundle & Prevention

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.

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-29
Primary Completion
2020-07-09
Completion
2020-07-14

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04347395 on ClinicalTrials.gov