NCT00715338

Brief Summary

Collect exhaled breath condensates from patients scheduled for a routine surgical procedure before, during, and after surgery for measurements of IsoFs Draw blood from patients scheduled for a routine surgical procedure before, during, and after surgery for measurements of serum thrombomodulin.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

July 10, 2008

Last Update Submit

April 19, 2017

Conditions

Lung Injury, Acute

Keywords

Exhaled Breath Condensateelective surgerymechanical ventilationIsofuransthrombomodulinrequiringmechanicalventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for a routine surgical procedure

You may qualify if:

  • American Society of Anesthesiologists (ASA) Class I-III.
  • Patient is undergoing elective surgery requiring mechanical ventilation
  • Patient is an adult, 18 - 80 years old.
  • Subject has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).

You may not qualify if:

  • Surgical procedures boarded for less than 2 hours
  • Current Smoker
  • All Cardiac, Thoracic and/or Vascular surgeries involving the chest
  • Patient unable to cooperate.
  • Chronic airway diseases
  • Asthma
  • Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder).
  • Subjects who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Links

Biospecimen

Retention: NONE RETAINED

serum

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Aspiration

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John A Barwise, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssistant Professor

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 15, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

US(1)