Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

NCT ID: NCT03844568

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2021-02-08

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.

Conditions

Aspiration Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

nasal CPAP group

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

Group Type: EXPERIMENTAL

nocturnal nasal continuous positive airway pressure

Intervention Type: DEVICE

applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime

Control group

Usual pneumonia treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

nocturnal nasal continuous positive airway pressure

applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eun Sun Kim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eun Sun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-1809-493-002

Identifier Type: -

Identifier Source: org_study_id