Forced Oscillation Versus Spirometry in Diagnosing Post P... | NCT01807975

Studies
Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome

NCT01807975

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Jul 28, 2016Estimated

Enrollment

110Actual

Phase

Not Applicable

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Forced oscillation

Countries

France

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

May 2016

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

Sep 2011

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 7, 2013

First Submission Date that Met QC Criteria

Mar 7, 2013

First Posted Date

Mar 8, 2013Estimated

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

Jul 27, 2016

Last Update Posted Date

Jul 28, 2016Estimated

Description Module

Brief Summary

A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).

Detailed Description

Not provided

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

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
post allogreffe patients	Experimental	Functional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients	Other: Forced oscillation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Forced oscillation	Other		post allogreffe patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of more than 18 year-old.
Patients with cardiopulmonary transplant or bilateral lung transplant.
Clinically stable patients

Exclusion Criteria:

Patients already diagnosed with bronchiolitis obliterans.
Respiratory infection.
Acute graft rejection.
Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
Iatrogenic pneumopathy.
Inability to perform Respiratory function test.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital FOCH		Suresnes	Île-de-France Region	92150	France

Condition Browse Module

MeSH Terms

ID	Term
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis

Browse Leaves

Not provided

Browse Branches

Not provided