PneumoniaNCT04347395
Respiratory Infection in Older Patients
A study testing Respiratory Bundle & Prevention in people with Pneumonia and Respiratory Infection, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pneumonia, Respiratory Infection, Dysphagia
- What is being tested?
- Respiratory Bundle & Prevention
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Jan 2016to 14 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- hospitalized geriatric patients >65 years age
- likely hospital length of stay >72 hours.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Respiratory Infections in Older Patients During and After Hospitalisation: A Randomised Controlled Trial
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.
Read the detailed description
Background:
Hospital-acquired infections impact patient recovery and increase risk of deterioration. Pneumonia is the second commonest cause of death in Singapore accounting for 19% of deaths in 2014. Hospital acquired pneumonia (HAP) or nosociomal pneumonia refers to any pneumonia contracted by a patient in a hospital at least 48-72 hours after admission and is usually caused by a bacterial infection, rather than a virus. It is the most prevalent hospital-acquired infection, and has the highest mortality among the hospital-acquired infections (20-50%) . Local audit data has shown that around 60% of deaths in hospitalised older patients are due to pneumonia, of which a significant proportion are due to HAP or health care associated pneumonia (HCAP).
A meta-analysis of respiratory studies has shown low numbers of studies evaluating novel antimicrobial agents for hospital-acquired pneumonia (15.9%) suggesting further research or novel approaches are needed. The prevalence of nosociomal pneumonia in a European study was 13.9%. Pneumonia acquired during periods of hospitalisation has a high morbidity, mortality and increased hospital length of stay (LOS). Audit of the 2014 data from the Geriatric Mortality meetings has shown all cause pneumonia (community acquired pneumonia (CAP) and HAP) is 55%. Currently this data is being analysed to calculate the proportion of deaths attributable to HAP vs CAP.
The pathophysiology of pneumonia in the elderly is primarily due to aspiration pneumonia (ASP). ASP comprises predominantly two pathological conditions: airspace infiltration with bacterial pathogens and dysphagia-associated aspiration. The primary route of infection is believed to be through microaspiration of organisms that have colonised the oropharynx and gastrointestinal tract. Hospitalised patients become colonised with microorganisms from the hospital environment within 48 hours and severity of respiratory infection is related to the number and virulence of these microorganisms as well as the hosts immune response.
Swallowing difficulties, poor oral hygiene and reduced immune response are inherent in the older population contributing to an increased risk of HAP. In addition, older patients have an increased risk of aspiration of gastric contents due to a laxity of lower oesphageal sphincter, an anatomical sphincter that relies on diaphragmatic function. Many older patients locally are fed via naso-gastric tube and the presence of a naso-gastric tube increases the risk of aspiration pneumonia occuring during hospitalisation. Supine positioning also predisposes to micro aspiration from the oropharynx and stomach with many patients placed routinelyin a supine position to undertake their basic care needs. Positioning in the semi recumbant position has been shown to reduce microaspiration with elevations of 30-45 degrees by improving supraglottic drainage.
Patients cared for in intensive care units have been shown to benefit from a targeted bundle of care that reduced ventilator associated pneumonia (VAP) and it is therefore likely that these principles could be extended to benefit older patients. The VAP bundle includes head up tilt (30 degrees), gastric acid suppression and good oral hygiene. In this study, gastric acid suppression will not be used routinely as some studies have suggested that the use of proton pump inhibitors may increase the risk of HAP. Research has shown reduced pneumonia rates and hospital re-admissions after the implementation of good oral care methods and a local quality improvement project (Bright Smiles) has been shown to improve the quality of oral care in older patients. Assessment of swallowing function at an early stage within the hospital admission offers the opportunity to identify earlier those patients with swallowing difficulties and intervene to reduce the likelihood of aspiration.
In a Spanish prospective multicenter case-control study of patients with HCAP or CAP more than 50% were due to streptococcus pneumoniae and the presence of multiple co-morbidities were associated with HCAP. In older patients with multiple co-morbidities there is poor uptake of vaccination and therefore the utilization of a vaccination programme for these patients proposes to reduce the likelihood of re-admission due to HCAP or HAP and aims to impact the hospital re-admission rates in geriatric patients.
The local data has identified the need for a novel approach to hospital acquired infections and the techniques described have shown benefit in ventilated patients but this study aims to extend the principle of preventing aspiration to a wider population of "at risk" older patients through positioning, swallowing assessment and good oral care.
The study planned is a randomized control trial (intervention arm vs control arm) to compare current best practice with a respiratory bundle of care.
- Conditions
- Pneumonia, Respiratory Infection, Dysphagia
- Being tested
- Respiratory Bundle & Prevention
- Keywords
- clinical trial, pneumonia, vaccination, geriatric, respiratory infection, dysphagia
- Medical subject headings
- Pneumonia, Respiratory Tract Infections, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Bundle & PreventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control Group | No intervention | Current best practice for prevention of HAP |
| Group 2: Intervention | Experimental | Respiratory Bundle Intervention Receives: Procedure: Respiratory Bundle & Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Older Patients (>65 years age)
To reduce the incidence of HAP
Measured: 9.5months
Secondary outcomes (1)
In Older Patients (>65 years age)
To reduce the 90 day mortality from HAP To reduce the hospital 30 day re-admission rate for Geriatric patients To reduce the 90 day re-admission rate for HCAP in Geriatric patients
Measured: 9.5months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start29 Jan 2016
- Primary completion9 Jul 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347395
- Sponsor's protocol ID
- 2015/3138
- Status last verified
- Oct 2020
- First submitted
- 14 Apr 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34081314
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Respiratory Infections in Older Patients During and After Hospitalisation: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04347395
- Acronym / sponsor ID
- 2015/3138
- Conditions
- Pneumonia, Respiratory Infection, Dysphagia
- Keywords
- clinical trial, pneumonia, vaccination, geriatric, respiratory infection, dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 29 Jan 2016 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Hospital-acquired infections impact patient recovery and increase risk of deterioration. Pneumonia is the second commonest cause of death in Singapore accounting for 19% of deaths in 2014. Hospital acquired pneumonia (HAP) or nosociomal pneumonia refers to any pneumonia contracted by a patient in a hospital at least 48-72 hours after admission and is usually caused by a bacterial infection, rather than a virus. It is the most prevalent hospital-acquired infection, and has the highest mortality among the hospital-acquired infections (20-50%) . Local audit data has shown that around 60% of deaths in hospitalised older patients are due to pneumonia, of which a significant proportion are due to HAP or health care associated pneumonia (HCAP).
A meta-analysis of respiratory studies has shown low numbers of studies evaluating novel antimicrobial agents for hospital-acquired pneumonia (15.9%) suggesting further research or novel approaches are needed. The prevalence of nosociomal pneumonia in a European study was 13.9%. Pneumonia acquired during periods of hospitalisation has a high morbidity, mortality and increased hospital length of stay (LOS). Audit of the 2014 data from the Geriatric Mortality meetings has shown all cause pneumonia (community acquired pneumonia (CAP) and HAP) is 55%. Currently this data is being analysed to calculate the proportion of deaths attributable to HAP vs CAP.
The pathophysiology of pneumonia in the elderly is primarily due to aspiration pneumonia (ASP). ASP comprises predominantly two pathological conditions: airspace infiltration with bacterial pathogens and dysphagia-associated aspiration. The primary route of infection is believed to be through microaspiration of organisms that have colonised the oropharynx and gastrointestinal tract. Hospitalised patients become colonised with microorganisms from the hospital environment within 48 hours and severity of respiratory infection is related to the number and virulence of these microorganisms as well as the hosts immune response.
Swallowing difficulties, poor oral hygiene and reduced immune response are inherent in the older population contributing to an increased risk of HAP. In addition, older patients have an increased risk of aspiration of gastric contents due to a laxity of lower oesphageal sphincter, an anatomical sphincter that relies on diaphragmatic function. Many older patients locally are fed via naso-gastric tube and the presence of a naso-gastric tube increases the risk of aspiration pneumonia occuring during hospitalisation. Supine positioning also predisposes to micro aspiration from the oropharynx and stomach with many patients placed routinelyin a supine position to undertake their basic care needs. Positioning in the semi recumbant position has been shown to reduce microaspiration with elevations of 30-45 degrees by improving supraglottic drainage.
Patients cared for in intensive care units have been shown to benefit from a targeted bundle of care that reduced ventilator associated pneumonia (VAP) and it is therefore likely that these principles could be extended to benefit older patients. The VAP bundle includes head up tilt (30 degrees), gastric acid suppression and good oral hygiene. In this study, gastric acid suppression will not be used routinely as some studies have suggested that the use of proton pump inhibitors may increase the risk of HAP. Research has shown reduced pneumonia rates and hospital re-admissions after the implementation of good oral care methods and a local quality improvement project (Bright Smiles) has been shown to improve the quality of oral care in older patients. Assessment of swallowing function at an early stage within the hospital admission offers the opportunity to identify earlier those patients with swallowing difficulties and intervene to reduce the likelihood of aspiration.
In a Spanish prospective multicenter case-control study of patients with HCAP or CAP more than 50% were due to streptococcus pneumoniae and the presence of multiple co-morbidities were associated with HCAP. In older patients with multiple co-morbidities there is poor uptake of vaccination and therefore the utilization of a vaccination programme for these patients proposes to reduce the likelihood of re-admission due to HCAP or HAP and aims to impact the hospital re-admission rates in geriatric patients.
The local data has identified the need for a novel approach to hospital acquired infections and the techniques described have shown benefit in ventilated patients but this study aims to extend the principle of preventing aspiration to a wider population of "at risk" older patients through positioning, swallowing assessment and good oral care.
The study planned is a randomized control trial (intervention arm vs control arm) to compare current best practice with a respiratory bundle of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control Group | No intervention | –Current best practice for prevention of HAP |
| Group 2: Intervention | Experimental | Procedure: Respiratory Bundle & PreventionRespiratory Bundle Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- hospitalized geriatric patients >65 years age
- likely hospital length of stay >72 hours.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Bundle & PreventionThe 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. | Procedure or surgery | Group 2: Intervention |
Primary outcome
In Older Patients (>65 years age)
Time frame: 9.5months
To reduce the incidence of HAP
1 secondary outcome
In Older Patients (>65 years age)
Time frame: 9.5months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34081314Rosario 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Bundle & Prevention in people with Pneumonia and Respiratory Infection, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Older Patients (>65 years age) (time frame: 9.5months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.