Aspiration Pneumonia
Conditions
Keywords
aspiration pneumonia, continuous positive airway pressure, CPAP
Brief 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). 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.
Interventions
DEVICEnocturnal nasal continuous positive airway pressure
applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 1. New or increased cough 2. Abnormal temperature (\< 35.6℃ or \> 37.8℃) 3. 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 1. Altered mental status 2. Gastrointestinal disorder 3. Dysphagia or swallowing difficulties 4. Esophageal motility disorders 5. Tracheostomy state 6. Enteral tube feeding * Informed consent
Exclusion criteria
* 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 * Pregnancy * Withdrawal of consent * Refusal of treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical stability-respiration (CS-r) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early clinical stability rate | 3 days | day 3 clinical stability rate |
| Late clinical stability rate | 7 days | day 7 clinical stability rate |
| Hospital length of stay | 1 day (during hospital admission) | length of hospital admission |
| Time to clinical stability | up to 2 weeks | time to clinical stabilization |
| Broadening of antimicrobial spectrum | 1 day (during hospital admission) | escalation antibiotics |
| Frequency of bronchoscopy for toileting | 1 day (during hospital admission) | frequency of invasive lung care like bronchoscopy |
| In-hospital mortality | 1 day (during hospital admission) | all cause mortality |
| Radiological improvement | 3 and 7 days | improvement of lung infiltration or atelectasis |
Countries
South Korea
Outcome results
None listed