NCT02817035

Brief Summary

To make these definitions of neural inspiratory time (Ti) and expiratory delay clearly.The present study was undertaken to examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

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
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

June 16, 2016

Last Update Submit

November 13, 2016

Conditions

Keywords

interstitial lung diseasechronic obstructive pulmonary diseasemechanical ventilationexpiratory delayneural inspiratory time

Outcome Measures

Primary Outcomes (1)

  • neural inspiratory time

    Compare the neural inspiratory time during spontaneous breathing and noninvasive mechanical ventilation.

    20-30 minutes

Secondary Outcomes (1)

  • expiratory delay

    20-30 minutes

Study Arms (1)

noninvasive mechanical ventilation

EXPERIMENTAL

To investigate the change of the neural inspiratory time and expiratory delay noninvasive mechanical ventilation ,in comparison to spontaneous breathing

Device: noninvasive mechanical ventilation

Interventions

To examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.

noninvasive mechanical ventilation

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic obstructive pulmonary disease patient meet the diagnose criteria of chronic obstructive pulmonary disease
  • interstitial lung disease patient meet the diagnose criteria of interstitial lung disease
  • healthy subjects No history of the lung and Cardiovascular disease.The lung function is normal.

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
  • High aspiration risk
  • Viscous or copious secretions
  • Recent facial or gastroesophageal surgery
  • Craniofacial trauma
  • Fixed nasopharyngeal abnormalities
  • Burns
  • Extreme obesity

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, InterstitialPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • rongchang chen, MD

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 29, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations