DysphagiaNCT01974089

Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia

An observational study of Dysphagia and Pneumonia, run by Regionshospital Nordjylland at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark. The endpoints will be re-hospitalisation and mortality. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia, Pneumonia
What is being tested?: Dysphagia
How many people: 154 participants
Where: 1 siteDenmark
Study dates: Oct 2013to Mar 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hospitalized patients recruited from the Department of Respiratory Medicine at North Denmeark Regional Hospital.

Who may be able to join

Temperature > 38 degrees Celcius
New infiltrate on chest x-ray
Increased C-reactive protein (CRP)
Either cough, dyspnea, pleuritic chest pain, expectoration, or tachypnea

Who cannot join

patients referred from the intensive care unit
reduced cognitive awareness if not able to able to cooperate with the assessment of oropharyngeal dysphagia

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Vendsyssel Hospital
Hjørring, 9800

Other trials in Denmark

About this study

This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark.

The endpoints will be re-hospitalisation and mortality.

Read the detailed description

Community acquired pneumonia (CAP) is an important cause of morbidity and mortality in elderly patients. Risk factors are many including oropharyngeal dysphagia (OD). Systematic screening of OD is recommended for at-risk popolations, however these resommandations do not specifically address elderly patients hospitalized with CAP.

In this study OD is assessed in all patients by Volume-Viscosity Swallowing Test (V-VST) The study is registered by the Danish Data Protection Authority (2008-58-0028)

Conditions: Dysphagia, Pneumonia
Being tested: Dysphagia
Keywords: Dysphagia, Community acquired pneumonia, Mortality, Rehospitalization
Medical subject headings: Deglutition Disorders, Pneumonia, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DysphagiaOther
Oropharyngeal dysphagia assessed by Volume-Viscosity Svallowing Test

Study groups in NCT01974089
Study group	Role	What they receive
Pneumonia and dysphagia		Patients with community aquired pneumonia and oropharyngea dysphagia Receives: Other: Dysphagia
Pneumonia		Patients with community aquired pneumonia

What is being measured

The primary outcome is the main question the study is designed to answer.

Intra Hospital Mortality
Intra hospital mortality is death while the patient is hospitalized
Measured: With in 10 days from admission
30 Day Mortality
Death within 30 days of discharge
Measured: 30 days after discharge
Re-hospitalization
The rate of re-hospitalization within 30 days of discharge
Measured: 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Mar 2014

First posted1 Nov 2013 (estimated)
Study startOct 2013
Primary completionOct 2013
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DysphagiaStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01974089
Sponsor's protocol ID: RHN_DMK_03
Status last verified: Apr 2019
First submitted: 25 Oct 2013
Last updated: 24 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia
ClinicalTrials.gov ID: NCT01974089
Acronym / sponsor ID: RHN_DMK_03
Conditions: Dysphagia, Pneumonia
Keywords: Dysphagia, Community acquired pneumonia, Mortality, Rehospitalization
Study type: Observational
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Regionshospital NordjyllandOther government
Study start: Oct 2013
Primary completion: Oct 2013 (actual)
Study completion: Mar 2014 (actual)
First posted: 1 Nov 2013 (estimated)
Results: Posted 1 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark.

The endpoints will be re-hospitalisation and mortality.

Detailed description

In this study OD is assessed in all patients by Volume-Viscosity Swallowing Test (V-VST) The study is registered by the Danish Data Protection Authority (2008-58-0028)

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pneumonia and dysphagia	–	Other: DysphagiaPatients with community aquired pneumonia and oropharyngea dysphagia
Pneumonia	–	–Patients with community aquired pneumonia

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hospitalized patients recruited from the Department of Respiratory Medicine at North Denmeark Regional Hospital.

Key inclusion criteria (4 listed)

Temperature > 38 degrees Celcius
New infiltrate on chest x-ray
Increased C-reactive protein (CRP)
Either cough, dyspnea, pleuritic chest pain, expectoration, or tachypnea

Key exclusion criteria (2 listed)

patients referred from the intensive care unit
reduced cognitive awareness if not able to able to cooperate with the assessment of oropharyngeal dysphagia

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
DysphagiaOropharyngeal dysphagia assessed by Volume-Viscosity Svallowing Test	Other	Pneumonia and dysphagia

Primary outcome

Intra Hospital Mortality
Time frame: With in 10 days from admission
Intra hospital mortality is death while the patient is hospitalized
30 Day Mortality
Time frame: 30 days after discharge
Death within 30 days of discharge
Re-hospitalization
Time frame: 30 days after discharge
The rate of re-hospitalization within 30 days of discharge

Results and safety

Results posted to the registry on 1 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pneumonia and Dysphagia	53	53
Pneumonia	101	101

Primary outcome: Intra Hospital Mortality

Time frame: With in 10 days from admission. Count of participants. Unit: Participants

Measure	Pneumonia and Dysphagia n = 53	Pneumonia n = 101
Value	7	0

Primary outcome: 30 Day Mortality

Time frame: 30 days after discharge. Count of participants. Unit: Participants

Measure	Pneumonia and Dysphagia n = 46	Pneumonia n = 101
Value	10	2

Primary outcome: Re-hospitalization

Time frame: 30 days after discharge. Count of participants. Unit: Participants

Measure	Pneumonia and Dysphagia n = 46	Pneumonia n = 101
Value	10	15

Adverse events

Time frame: Adverse events reported until 30 days after discharge from hospital. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pneumonia and Dysphagia	0 of 53 (0%)	0 of 53 (0%)	17 of 53
Pneumonia	0 of 101 (0%)	0 of 101 (0%)	2 of 101

Limitations and caveats (from the sponsor): Small sample size. The definition of community acquired pneumonia is vague and unclear and there is a risk that some patients may be hospitalized with aspiration pneumonia, a subtype of community acquired pneumonia.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dysphagia

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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Recruiting
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Not yet recruitingPhase 2
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Active, not recruitingObservational study
RETHINK REFLUX Registry
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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?

An observational study of Dysphagia and Pneumonia, run by Regionshospital Nordjylland at 1 site in Denmark.

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 4 inclusion and 2 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 24 Apr 2019. 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 Denmark. 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?

Yes. Results are posted in the registry (first posted 1 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intra Hospital Mortality (time frame: With in 10 days from admission). The study lists 3 primary outcomes in all. 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 NCT01974089.

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 24 Apr 2019.