Comparison of Central Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter

NCT01788956 | Unknown

• 1 other identifier: MLS STP-9100002
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The intent of this study is to validate the venous blood oxygenation measurements of the Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is currently the standard of care for measuring SvO2

Conditions

Sepsis; Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy; Cardiogenic Shock Post Myocardial Infarction; Hypoxemic Respiratory Failure.

Keywords

venous oximeter; CO-Oximeter; ICU Patients; Sepsis; non-invasive device

Outcome Measures

Primary Outcomes (1)

• Mespere Venous Oximeter Accuracy Verification Study

  up to 36 hours

Study Arms (1)

ICU Patients

80 subjects (male and female)

Device: Mespere Venous Oximeter; Device: Co-Oximeter

Interventions

Mespere Venous Oximeter DEVICE

Mespere Venous oximeter provides non-invasive measurement of the oxygenation of the venous blood.

ICU Patients

Co-Oximeter DEVICE

ICU Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will consist of patients admitted either to the Medical Surgical ICU or the Cardiac Surgery Recovery Unit at University Hospital. The four groups will comprise patients with the following diagnoses: i) sepsis +/- septic shock, ii) post cardiac surgery low output syndrome requiring inotropic/vasopressor therapy, iii) cardiogenic shock post myocardial infarction, and iv) hypoxemic respiratory failure.

You may qualify if:

• Age 18 and older
• Patients admitted to the ICU
• Patients who have or are scheduled to have an indwelling central venous catheter inserted via the internal jugular vein or subclavian vein as part of their usual care

You may not qualify if:

• Abnormal neck anatomy
• Unable to identify jugular vein under ultrasound guidance
• Allergic to adhesive tape
• Presence of known anatomical shunt or AV dialysis fistula
• Known central vein stenosis

Sponsors & Collaborators

• Mespere Lifesciences Inc.: lead

Study Sites (1)

London Health Sciences Center, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Sepsis; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Michael Sharpe, MD, FRCPC

  LHSC University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

CA (1)