NCT02012101

Brief Summary

The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

December 8, 2013

Last Update Submit

June 23, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDdyspneaexerciseNoninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • Borg scale

    baseline,repeated measurement for about ten minutes after intervention

Secondary Outcomes (7)

  • Inspiratory capacity(IC)

    baseline,repeated measurement for about ten minutes after intervention

  • surface electromyography(sEMG)

    baseline,repeated measurement for about ten minutes after intervention

  • respiratory parameters

    baseline,repeated measurement for about ten minutes after intervention

  • oxygen saturation(SpO2)

    baseline,repeated measurement for about ten minutes after intervention

  • Heart Rate(HR)

    baseline,repeated measurement for about ten minutes after intervention

  • +2 more secondary outcomes

Study Arms (2)

niv plus oxygen therapy

EXPERIMENTAL

oxygen therapy is given during the whole experimental process, niv is given at peak exercise until the borg scale reaches it's baseline point

Device: niv plus oxygen therapy

oxygen therapy

ACTIVE COMPARATOR

oxygen therapy is given during the whole experimental process

Device: oxygen therapy

Interventions

niv plus oxygen therapyDEVICE

NIV given on Philips Respironics BiPAP Vision apparatus.

Also known as: Philips Respironics BiPAP Vision
niv plus oxygen therapy
oxygen therapyDEVICE
oxygen therapy

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe COPD (post bronchodilator FEV1/FVC \< 70% and FEV1 \< 50% predicted)
  • stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
  • dyspnea as a main symptom that limited daily activities

You may not qualify if:

  • obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination
  • facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
  • oxygen saturation(SpO2) \< 88% at rest with a fraction of inspired oxygen(FiO2) ≥ 0.5
  • systolic blood pressure \> 160mmHg or diastolic blood pressure \> 100mmHg at rest
  • unstable angina or a myocardial infarct in the previous four weeks
  • resting sinus tachycardia ( \> 120 beats/min)
  • patients with musculoskeletal or neurological disorders
  • patients who are unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaMotor Activity

Interventions

Noninvasive VentilationOxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Rongchang Chen, M.D.

    Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MMSc

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 16, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

CN(1)