Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

NCT03844568 | Withdrawn DMC

• 1 other identifier: B-1809-493-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

aspiration pneumonia; continuous positive airway pressure, CPAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time to clinical stability

  up to 2 weeks

• Early clinical stability rate

  3 days

• Late clinical stability rate

  7 days

• Hospital length of stay

  1 day (during hospital admission)

• Radiological improvement

  3 and 7 days

Study Arms (2)

nasal CPAP group

EXPERIMENTAL

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

Device: nocturnal nasal continuous positive airway pressure

Control group

NO INTERVENTION

Usual pneumonia treatment

Interventions

nocturnal nasal continuous positive airway pressure DEVICE

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

nasal CPAP group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Pneumonia, Aspiration; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eun Sun Kim, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 18, 2019
• Study Start: March 18, 2019
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)