NCT04212559

Brief Summary

Negative pressure ventilation (NPV) is a non-invasive ventilation mode which provide better lung expansion. The major complication of NPV is decrease blood pressure and affects the hemodynamics. The effects of NPV on chronic obstructive pulmonary disease (COPD) patients with pulmonary rehabilitation program remains unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 27, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 18, 2020

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

November 16, 2019

Last Update Submit

January 13, 2020

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

  • CO (cardiac output)

    Change of Cardiac output before and after NPV treatment

    20 minutes

  • SV (stroke volume)

    Change of stroke volume before and after NPV treatment

    20 minutes

Secondary Outcomes (2)

  • SpO2

    20 minutes

  • RR (respiratory rate)

    20 minutes

Study Arms (1)

NPV group

Patients who had treated in pulmonary rehabilitation unit with NPV

Other: Received negative pressure ventilation

Interventions

Received negative pressure ventilationOTHER

Patients who received a negative pressure during inspiratory phase.

NPV group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD

You may qualify if:

  • Patients with COPD who received pulmonary rehabilitation program with NPV treatment

You may not qualify if:

  • Recent exacerbation within 3-months
  • Existing of tracheostomy
  • Absence of NPV used
  • Required of oxygen supplement during NPV
  • Diagnosed of neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Respiratory Therapist

Study Record Dates

First Submitted

November 16, 2019

First Posted

December 27, 2019

Study Start

January 1, 2018

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

January 18, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)