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Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula

Primary Purpose

Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nasal Pillow CPAP
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Failure focused on measuring Electrical impedance tomography, Nasal Pillow Continuous Positive Airway Pressure(CPAP), High Flow Nasal Cannula, extubation

Eligibility Criteria

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

Inclusion Criteria:

  • >20 y/o
  • Any extubated patients after tolerating spontaneous breathing trial

Exclusion Criteria:

  • Presence of tracheostomy
  • Recent facial trauma
  • Active gastro-intestinal bleeding
  • Do-not-intubate status and
  • Planned use of BiPAP after extubation.
  • Patients with unstable spinal lesions or fractures.
  • BMI> 50
  • Patients with a cardiac pacemaker
  • Burn injury with skin defect

Sites / Locations

  • Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nasal pillow CPAP

Arm Description

Nasal pillow CPAP

Outcomes

Primary Outcome Measures

• End-expiratory lung volume (EELV) determined by electrical impedance tomography after high flow nasal cannula and nasal pillow CPAP

Secondary Outcome Measures

Anterior, medio-anterior, medio-posterior and posterior EELV at each time

Full Information

First Posted
October 27, 2014
Last Updated
December 11, 2014
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02292992
Brief Title
Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula
Official Title
The Difference of Lung Volume Change Detected by Electrical Impedance Tomography (EIT) Between Noninvasive Positive-pressure Ventilation (NIPPV) Support by Nasal Pillow and High Flow Nasal Cannula in Post-extubation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients.
Detailed Description
Electrical impedance tomography can effectively monitor the lung volume change in ICU patients who were under mechanical ventilator or noninvasive positive pressure ventilator support. Continuous positive airway pressure (CPAP) support by nasal pillow and high flow nasal cannula can improve inspiratory function in extubated patients . However, the extent of lung volume change or functional residual volume (FRC) change by using these two devices were never surveyed before in extubated patients. The investigators will check end-expiratory lung volume (EELV) ,anterior, medio-anterior, medio-posterior and posterior EELV by electrical impedance tomography after use of these two devices in extubated patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Electrical impedance tomography, Nasal Pillow Continuous Positive Airway Pressure(CPAP), High Flow Nasal Cannula, extubation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal pillow CPAP
Arm Type
Experimental
Arm Description
Nasal pillow CPAP
Intervention Type
Device
Intervention Name(s)
Nasal Pillow CPAP
Intervention Description
Nasal Pillow CPAP in extubated patients
Primary Outcome Measure Information:
Title
• End-expiratory lung volume (EELV) determined by electrical impedance tomography after high flow nasal cannula and nasal pillow CPAP
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Anterior, medio-anterior, medio-posterior and posterior EELV at each time
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >20 y/o Any extubated patients after tolerating spontaneous breathing trial Exclusion Criteria: Presence of tracheostomy Recent facial trauma Active gastro-intestinal bleeding Do-not-intubate status and Planned use of BiPAP after extubation. Patients with unstable spinal lesions or fractures. BMI> 50 Patients with a cardiac pacemaker Burn injury with skin defect
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo Li Kuo, MD
Phone
+886975835135
Email
lmn4093@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Chao-Hsien, MD
Organizational Affiliation
+886975835770 l49428@mmh.org.tw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuo Li Kuo, MD

12. IPD Sharing Statement

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Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula

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