NCT01661374

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

August 6, 2012

Last Update Submit

December 9, 2014

Conditions

Chronic Obstructive Pulmonary Disease(COPD)

Outcome Measures

Primary Outcomes (1)

  • Sputum Collection

    Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of sputum.

    10 minutes

Study Arms (2)

Mechanically Ventilated

Chronic obstructive pulmonary disease (COPD).

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic,ICU, Pulmonary Clinic

You may qualify if:

  • Any Subject Mechanically Ventilated and producing sputum.

You may not qualify if:

  • None
  • COPD Group
  • to 90 years of age suffering from COPD
  • History of mucus production
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruce K Rubin, MEngr, MD, MBA, FRCPC

    Virginia Commonwealth University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 9, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(1)