The Effect of Humidification on Mucus Rheology | NCT01661374

Studies
The Effect of Humidification on Mucus Rheology

NCT01661374

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Dec 10, 2014Estimated

Enrollment

18Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease(COPD)

Interventions

Not provided

Countries

United States

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

Dec 2014

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 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Aug 6, 2012

First Submission Date that Met QC Criteria

Aug 8, 2012

First Posted Date

Aug 9, 2012Estimated

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

Dec 9, 2014

Last Update Posted Date

Dec 10, 2014Estimated

Name	Class
Fisher and Paykel Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study the investigators will collect mucus from mechanical ventilated patients and patients with COPD to study the effect of temperature and humidity, on the biophysical properties of the airway mucus. It is hypothesised that changes in inspired gas temperature and humidity (over time) may affect the biophysical properties of the airway mucus and reduce the airway's ability to clear mucus, resulting in deleterious clinical affects.

Detailed Description

Expectorated sputum samples are collected and used to measure the biophysical properties of mucus secretions. The samples are later exposed to different temperatures and humidity levels during bench experiments.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sputum Collection	Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of sputum.	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Mechanically Ventilated Patients

Inclusion Criteria:

Any Subject Mechanically Ventilated and producing sputum.

Exclusion

None

COPD Group

Inclusion Criteria:

40 to 90 years of age suffering from COPD
History of mucus production

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Primary Care Clinic,ICU, Pulmonary Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce K Rubin, MEngr, MD, MBA, FRCPC	Virginia Commonwealth University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23284	United States

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Mechanically Ventilated
Chronic obstructive pulmonary disease (COPD).