Respiratory Infection in Older Patients

NCT04347395 | Completed

• 1 other identifier: 2015/3138
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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

Pneumonia; Respiratory Infection; Dysphagia

Keywords

clinical trial; pneumonia; vaccination; geriatric; respiratory infection; dysphagia

Outcome Measures

Primary Outcomes (1)

• In Older Patients (>65 years age)

  To reduce the incidence of HAP

  9.5months

Secondary Outcomes (1)

• In Older Patients (>65 years age)

  9.5months

Study Arms (2)

Group 1: Control Group

NO INTERVENTION

Current best practice for prevention of HAP

Group 2: Intervention

EXPERIMENTAL

Respiratory Bundle Intervention

Procedure: Respiratory Bundle & Prevention

Interventions

Respiratory Bundle & Prevention PROCEDURE

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.

Group 2: Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• hospitalized geriatric patients \>65 years age
• likely hospital length of stay \>72 hours.

You may not qualify if:

• participants \< 65 years;
• spinal cord injury;
• pneumonia or chest infection as admission diagnosis;
• active cancer of the respiratory tract;
• pressure ulcer grade 3, grade 4 or unstageable;
• hospital admission likely to be \<72 hours.

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34081314 DERIVED

MeSH Terms

Conditions

Pneumonia; Respiratory Tract Infections; Deglutition Disorders

Condition Hierarchy (Ancestors)

Infections; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 15, 2020
• Study Start: January 29, 2016
• Primary Completion: July 9, 2020
• Study Completion: July 14, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

SG (1)