Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

Conditions
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Aspiration Pneumonia

Intervention / Treatment
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* Device: nocturnal nasal continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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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 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 Altered mental status Gastrointestinal disorder Dysphagia or swallowing difficulties Esophageal motility disorders Tracheostomy state 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nasal CPAP group<br>Applying nocturnal nasal continuous positive airway pressure in additional to usual pneumonia treatment | Device: nocturnal nasal continuous positive airway pressure<br>* applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime<br>|
| No Intervention: Control group<br>Usual pneumonia treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical stability | time to clinical stabilization | up to 2 weeks | 
| Early clinical stability rate | day 3 clinical stability rate | 3 days | 
| Late clinical stability rate | day 7 clinical stability rate | 7 days | 
| Hospital length of stay | length of hospital admission | 1 day (during hospital admission) | 
| Radiological improvement | improvement of lung infiltration or atelectasis | 3 and 7 days | 
| Broadening of antimicrobial spectrum | escalation antibiotics | 1 day (during hospital admission) | 
| Frequency of bronchoscopy for toileting | frequency of invasive lung care like bronchoscopy | 1 day (during hospital admission) | 
| In-hospital mortality | all cause mortality | 1 day (during hospital admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspiration pneumonia, continuous positive airway pressure, CPAP