NCT02292992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

October 27, 2014

Last Update Submit

December 11, 2014

Conditions

Respiratory Failure

Keywords

Electrical impedance tomographyNasal Pillow Continuous Positive Airway Pressure(CPAP)High Flow Nasal Cannulaextubation

Outcome Measures

Primary Outcomes (1)

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

    at day 1

Secondary Outcomes (1)

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

    at day 1

Study Arms (1)

Nasal pillow CPAP

EXPERIMENTAL

Nasal pillow CPAP

Device: Nasal Pillow CPAP

Interventions

Nasal Pillow CPAPDEVICE

Nasal Pillow CPAP in extubated patients

Nasal pillow CPAP

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Lee Chao-Hsien, MD

    +886975835770 l49428@mmh.org.tw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuo Li Kuo, MD

CONTACT

+886975835135lmn4093@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 18, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 15, 2014

Record last verified: 2014-12

Locations

TW(1)