NCT00865995

Brief Summary

Evaluation of tracheal pepsin as a biomarker for aspiration

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

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

February 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

4.8 years

First QC Date

March 19, 2009

Last Update Submit

October 22, 2013

Conditions

Keywords

pepsinaspirationGE reflux

Outcome Measures

Primary Outcomes (1)

  • pepsin concentration

    1 day

Study Arms (3)

1

patients undergoing elective procedures with intubation and no known respiratory pathology

Procedure: Tracheal Lavage

2

patients with tracheostomy

3

patients with chronic lung disease or respiratory symptoms undergoing bronchoscopy

Interventions

Tracheal Lavage will be performed on the control population patients and the tracheal fluid obtained from this procedure will be used as the research sample.

1

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normal children undergoing general endotracheal anesthesia Children with tracheostomies Children undergoing bronchoscopy Intubated children in PICU

You may qualify if:

  • Meet criteria of study population

You may not qualify if:

  • Lack of informed consent/assent
  • Pulmonary disease in normal controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tracheal fluid

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Nikki Johnston, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

February 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations