NCT04347395

Respiratory Infection in Older Patients

Completed NA Last updated 8 October 2020

What this trial tests

NA trial testing Respiratory Bundle & Prevention in Pneumonia in 123 participants. Completed in 14 July 2020.

Timeline

29 January 2016

Primary endpoint
9 July 2020

14 July 2020

Quick facts

Lead sponsor	Changi General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	123
Start date	29 January 2016
Primary completion	9 July 2020
Estimated completion	14 July 2020
Sites	1 location across Singapore

Drugs / interventions tested

• Respiratory Bundle & Prevention

Conditions studied

• Pneumonia — all drugs for Pneumonia →
• Respiratory Infection — all drugs for Respiratory Infection →
• Dysphagia — all drugs for Dysphagia →

Sponsor

Changi General Hospital

Who can join

65 and older, any sex, with Pneumonia or Respiratory Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of multi-component interventions for prevention of nosocomial pneumonia in older adults: a randomized, controlled trial.
   Rosario BH, Shafi H, Yii ACA, Tee LY, et al · · 2021 · cited 6× · PMID 34081314 · DOI 10.1007/s41999-021-00506-3