NCT02877121

Brief Summary

The purpose of this study is to assess the Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

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

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 19, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

August 10, 2016

Last Update Submit

December 16, 2016

Conditions

State Key Laboratory of Respiratory Disease

Keywords

interstitial lung diseaseRespiratory Muscle FunctionNeural Respiratory Drive

Outcome Measures

Primary Outcomes (1)

  • transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)

    20-30minutes

Secondary Outcomes (6)

  • the The diaphragm electromyogram (EMGdi)(10-300uv )

    20-30minutes

  • the negative airway pressure generated during the first 100 ms of an occluded (p0.1)(from -0.5 to -5cmH2O)

    20-30minutes

  • The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease

    20-30minutes

  • The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)

    20-30minutes

  • The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)

    20-30minutes

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Interstitial Lung Disease patients

You may qualify if:

  • Interstitial lung disease patient meet the diagnose criteria of interstitial lung disease

You may not qualify if:

  • Severe Cardiovascular disease
  • Pneumonia
  • Neuromuscular and chest wall deformity
  • Respiratory arrest
  • Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
  • Change in mental status; uncooperative patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TheFirst Affiliated Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 24, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-08

Locations

CN(1)