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

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.

Study Overview

• Status: Withdrawn
• Conditions: Aspiration Pneumonia
• Intervention / Treatment: Device: nocturnal nasal continuous positive airway pressure

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): February 8, 2021

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: aspiration pneumonia; continuous positive airway pressure, CPAP
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Aspiration
• Other Study ID Numbers: B-1809-493-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No