Aspiration PneumoniaNAPNCT03844568
Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
A study testing nocturnal nasal continuous positive airway pressure in people with Aspiration Pneumonia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Numerous elderly patients are suffering from aspiration pneumonia due to anatomical or functional predisposing factors including enteral tube feeding, swallowing difficulties, and gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- nocturnal nasal continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2019to 8 Feb 2021
- 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
- Age ≥ 65 years
- Diagnosis of pneumonia: the presence of new pulmonary infiltration in dependent areas on chest radiographs at the time of hospitalization with at least one of the following
- New or increased cough
- Abnormal temperature (< 35.6℃ or > 37.8℃)
- Abnormal serum leukocyte count (leukocytosis, left shift, or leukopenia)
- Aspiration tendency or risk factors for frequent or large volume aspiration with at least one of the following
Show all 13Show fewer
- Altered mental status
- Gastrointestinal disorder
- Dysphagia or swallowing difficulties
- Esophageal motility disorders
- Tracheostomy state
- Enteral tube feeding
- Informed consent
Who cannot join
- Severe hypercapnia (PaCO2 > 70mmHg)
- Respiratory arrest requiring tracheal intubation
- Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
- Failure of more than two organs
- Recent trauma or burns of the neck and face
- Non- cooperation
Show all 9Show fewer
- Pregnancy
- Withdrawal of consent
- Refusal of treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Numerous elderly patients are suffering from aspiration pneumonia due to anatomical or functional predisposing factors including enteral tube feeding, swallowing difficulties, and gastroesophageal reflux disease (GERD). Previous studies have been demonstrated that continuous positive airway pressure (CPAP) is an acceptable means of managing chronic aspiration, atelectasis, and GERD. The purpose of this study is to determine whether nocturnal nasal CPAP is beneficial in patients with aspiration pneumonia and that it would contribute to the rapid clinical stability of aspiration pneumonia.
- Conditions
- Aspiration Pneumonia
- Being tested
- nocturnal nasal continuous positive airway pressure
- Keywords
- aspiration pneumonia, continuous positive airway pressure, CPAP
- Medical subject headings
- Pneumonia, Aspiration, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nocturnal nasal continuous positive airway pressureDevice
applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime
| Study group | Role | What they receive |
|---|---|---|
| nasal CPAP group | Experimental | Applying nocturnal nasal continuous positive airway pressure in additional to usual pneumonia treatment Receives: Device: nocturnal nasal continuous positive airway pressure |
| Control group | No intervention | Usual pneumonia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical stability-respiration (CS-r)
time to respiratory stabilization (respiratory rate ≤ 24/min and arterial oxygen saturation ≥ 90% or a partial pressure of oxygen ≥ 60mmHg on room air or usual requirement level)
Measured: up to 2 weeks
Secondary outcomes (8)
Time to clinical stability
time to clinical stabilization
Measured: up to 2 weeks
Early clinical stability rate
day 3 clinical stability rate
Measured: 3 days
Late clinical stability rate
day 7 clinical stability rate
Measured: 7 days
Hospital length of stay
length of hospital admission
Measured: 1 day (during hospital admission)
Radiological improvement
improvement of lung infiltration or atelectasis
Measured: 3 and 7 days
Broadening of antimicrobial spectrum
escalation antibiotics
Measured: 1 day (during hospital admission)
Frequency of bronchoscopy for toileting
frequency of invasive lung care like bronchoscopy
Measured: 1 day (during hospital admission)
In-hospital mortality
all cause mortality
Measured: 1 day (during hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start18 Mar 2019
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Why it stopped: Hard to recruit due to COVID-19 issue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Eun Sun Kim, Seoul National University Bundang Hospital
- Investigators
- Eun Sun Kim, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844568
- Sponsor's protocol ID
- B-1809-493-002
- Acronym
- NAP
- Status last verified
- Apr 2023
- First submitted
- 15 Feb 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
- ClinicalTrials.gov ID
- NCT03844568
- Acronym / sponsor ID
- NAP / B-1809-493-002
- Conditions
- Aspiration Pneumonia
- Keywords
- aspiration pneumonia, continuous positive airway pressure, CPAP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hard to recruit due to COVID-19 issue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 18 Feb 2019 (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.
Numerous elderly patients are suffering from aspiration pneumonia due to anatomical or functional predisposing factors including enteral tube feeding, swallowing difficulties, and gastroesophageal reflux disease (GERD). Previous studies have been demonstrated that continuous positive airway pressure (CPAP) is an acceptable means of managing chronic aspiration, atelectasis, and GERD. The purpose of this study is to determine whether nocturnal nasal CPAP is beneficial in patients with aspiration pneumonia and that it would contribute to the rapid clinical stability of aspiration pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal CPAP group | Experimental | Device: nocturnal nasal continuous positive airway pressureApplying nocturnal nasal continuous positive airway pressure in additional to usual pneumonia treatment |
| Control group | No intervention | –Usual pneumonia treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Age ≥ 65 years
- Diagnosis of pneumonia: the presence of new pulmonary infiltration in dependent areas on chest radiographs at the time of hospitalization with at least one of the following
- Aspiration tendency or risk factors for frequent or large volume aspiration with at least one of the following
- Informed consent
Key exclusion criteria (9 listed)
- Severe hypercapnia (PaCO2 > 70mmHg)
- Respiratory arrest requiring tracheal intubation
- Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
- Failure of more than two organs
- Recent trauma or burns of the neck and face
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 |
|---|---|---|
| nocturnal nasal continuous positive airway pressureapplying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime | Device | nasal CPAP group |
Primary outcome
Time to clinical stability-respiration (CS-r)
Time frame: up to 2 weeks
time to respiratory stabilization (respiratory rate ≤ 24/min and arterial oxygen saturation ≥ 90% or a partial pressure of oxygen ≥ 60mmHg on room air or usual requirement level)
8 secondary outcomes
Time to clinical stability
Time frame: up to 2 weeks
Early clinical stability rate
Time frame: 3 days
Late clinical stability rate
Time frame: 7 days
Hospital length of stay
Time frame: 1 day (during hospital admission)
Radiological improvement
Time frame: 3 and 7 days
Broadening of antimicrobial spectrum
Time frame: 1 day (during hospital admission)
Frequency of bronchoscopy for toileting
Time frame: 1 day (during hospital admission)
In-hospital mortality
Time frame: 1 day (during hospital admission)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Eun Sun Kim, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nocturnal nasal continuous positive airway pressure in people with Aspiration Pneumonia, run by Seoul National University Hospital at 1 site in South Korea.
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 13 inclusion and 9 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: withdrawn, as of the sponsor's last update on 12 Apr 2023. 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 South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time to clinical stability-respiration (CS-r) (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.