Clinical trial NCT03844568: Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
Official title: Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aspiration Pneumonia
Keywords: aspiration pneumonia
continuous positive airway pressure, CPAP
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2019-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to clinical stability-respiration (CS-r)
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Time to clinical stability
timeFrame: up to 2 weeks
measure: Early clinical stability rate
timeFrame: 3 days
measure: Late clinical stability rate
timeFrame: 7 days
measure: Hospital length of stay
timeFrame: 1 day (during hospital admission)
measure: Radiological improvement
timeFrame: 3 and 7 days
measure: Broadening of antimicrobial spectrum
timeFrame: 1 day (during hospital admission)
measure: Frequency of bronchoscopy for toileting
timeFrame: 1 day (during hospital admission)
measure: In-hospital mortality
timeFrame: 1 day (during hospital admission)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Eun Sun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: