NCT03060369

BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot study aims to examine the relationship between continuously measured CareGuide™ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).

Detailed description

Approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (Cohort A). Noninvasive near-infrared spectroscopy CareGuide™ measurements of SmO2, tissue pH and hematocrit will be collected from enrollment through device removal. These data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the CareGuide™ monitoring period.

Conditions

• Shock

Interventions

Type	Name	Description
DEVICE	CareGuide™ device	CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2017-02-23
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States