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

Primary Purpose

Aspiration Pneumonia

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
nocturnal nasal continuous positive airway pressure
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspiration Pneumonia focused on measuring aspiration pneumonia, continuous positive airway pressure, CPAP

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

nasal CPAP group

Control group

Arm Description

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

Usual pneumonia treatment

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time to clinical stability
time to clinical stabilization
Early clinical stability rate
day 3 clinical stability rate
Late clinical stability rate
day 7 clinical stability rate
Hospital length of stay
length of hospital admission
Radiological improvement
improvement of lung infiltration or atelectasis
Broadening of antimicrobial spectrum
escalation antibiotics
Frequency of bronchoscopy for toileting
frequency of invasive lung care like bronchoscopy
In-hospital mortality
all cause mortality

Full Information

First Posted
February 15, 2019
Last Updated
April 10, 2023
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03844568
Brief Title
Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
Acronym
NAP
Official Title
Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Hard to recruit due to COVID-19 issue.
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia
Keywords
aspiration pneumonia, continuous positive airway pressure, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nasal CPAP group
Arm Type
Experimental
Arm Description
Applying nocturnal nasal continuous positive airway pressure in additional to usual pneumonia treatment
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual pneumonia treatment
Intervention Type
Device
Intervention Name(s)
nocturnal nasal continuous positive airway pressure
Intervention Description
applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime
Primary Outcome Measure Information:
Title
Time to clinical stability-respiration (CS-r)
Description
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)
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
Time to clinical stability
Description
time to clinical stabilization
Time Frame
up to 2 weeks
Title
Early clinical stability rate
Description
day 3 clinical stability rate
Time Frame
3 days
Title
Late clinical stability rate
Description
day 7 clinical stability rate
Time Frame
7 days
Title
Hospital length of stay
Description
length of hospital admission
Time Frame
1 day (during hospital admission)
Title
Radiological improvement
Description
improvement of lung infiltration or atelectasis
Time Frame
3 and 7 days
Title
Broadening of antimicrobial spectrum
Description
escalation antibiotics
Time Frame
1 day (during hospital admission)
Title
Frequency of bronchoscopy for toileting
Description
frequency of invasive lung care like bronchoscopy
Time Frame
1 day (during hospital admission)
Title
In-hospital mortality
Description
all cause mortality
Time Frame
1 day (during hospital admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Sun Kim, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia

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