Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

Not Applicable

Withdrawn

• Conditions: Aspiration Pneumonia
• Interventions: Device: nocturnal nasal continuous positive airway pressure

• Registration Number: NCT03844568
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Study Start: 2019-03-18
• Primary Completion: 2021-02-08
• Study Completion: 2021-02-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal CPAP group	nocturnal nasal continuous positive airway pressure	Applying nocturnal nasal continuous positive airway pressure in additional to usual pneumonia treatment

Primary Outcome Measures

Name	Time	Method
Time to clinical stability-respiration (CS-r)	up to 2 weeks	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of