Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia (NAP)

Seoul National University

Status: Withdrawn

Conditions: Aspiration Pneumonia

Treatments: Device: nocturnal nasal continuous positive airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03844568

B-1809-493-002

Details and patient eligibility

About

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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

nasal CPAP group

Experimental group

Description:

Applying nocturnal nasal continuous positive airway pressure in additional to usual pneumonia treatment

Treatment:

Device: nocturnal nasal continuous positive airway pressure

Control group

No Intervention group

Description:

Usual pneumonia treatment