Helmet Ventilation During Self-Paced Walking Test | NCT04156724

Studies
Helmet Ventilation During Self-Paced Walking Test

NCT04156724

Sponsor

Fu Jen Catholic University

Status

Completed

Last Update Posted

Sep 30, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

COPD

Interventions

Helmet vetilation

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2020Actual

Primary Completion Date

Feb 1, 2021Actual

Completion Date

Feb 1, 2021Actual

First Submitted Date

Nov 6, 2019

First Submission Date that Met QC Criteria

Nov 6, 2019

First Posted Date

Nov 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2021

Last Update Posted Date

Sep 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ke-Yun, Chao, Leader of Respiratory Therapist, Fu Jen Catholic UniversityPrincipal Investigator

Lead Sponsor

Fu Jen Catholic UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation with chronic inflammation of the respiratory system. Symptoms of COPD may contribute to activity restriction, deconditioning and exercise intolerance. Non-invasive positive pressure ventilation (NIPPV) has been shown to improve exercise intolerance and health-related quality of life in patients with severe COPD. Helmet ventilation (HV) is a new option for NIPPV to alternative to nasal or face mask. A study which published on JAMA demonstrated the feasibility and benefits of HV. The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HV	Experimental	6MWT with helmet ventilation	Device: Helmet vetilation
Control	No Intervention	6MWT alone according to ATS guideline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Helmet vetilation	Device	We will apply non-invasive positive pressure ventilation via a helmet as interface	HV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6WMD	Walking distance of six minute walking test	2 days

Secondary Outcomes

Measure	Description	Time Frame
Heart rate	Heart rate of six minute walking test	2 days
Respiratory rate	Respiratory rate of six minute walking test	2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patents with COPD who confirm by pulmonary function test

Exclusion Criteria:

COPD AE within 3 months
Diagnosed neuromuscular disease
Unable to perform 6-MWT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wen-Lun Liu, MD	Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fu Jen Catholic University Hospital, Fu Jen Catholic University		New Taipei City		24352	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27179847	Background	Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.
29595563	Background

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease