Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

Aspiration Pneumonia Clinical Trial

— NAP  

Official title:

Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03844568
• Other study ID #: B-1809-493-002
• Status: Withdrawn
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: February 8, 2021

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 8, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to clinical stability	time to clinical stabilization	up to 2 weeks
Secondary	Early clinical stability rate	day 3 clinical stability rate	3 days
Secondary	Late clinical stability rate	day 7 clinical stability rate	7 days
Secondary	Hospital length of stay	length of hospital admission	1 day (during hospital admission)
Secondary	Radiological improvement	improvement of lung infiltration or atelectasis	3 and 7 days
Secondary	Broadening of antimicrobial spectrum	escalation antibiotics	1 day (during hospital admission)
Secondary	Frequency of bronchoscopy for toileting	frequency of invasive lung care like bronchoscopy	1 day (during hospital admission)
Secondary	In-hospital mortality	all cause mortality	1 day (during hospital admission)