Assessment of Peripheral Perfusion in the Critically Ill Patient

Completed

• Conditions: Peripheral Perfusion
• Interventions: Device: Peripheral Perfusion index by Carescape Patientenmonitor

• Registration Number: NCT02771002
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral perfusion in patients in septic shock and after cardiac surgery.

Detailed Description

The aim of this study is to validate PPI as a continuous, objective measurement of peripheral perfusion indicated by clinical sings of tissue perfusion in patients with septic shock. Furthermore, PPI shall be compared to the perfusion of solid organs evaluated by ultrasound of liver, kidney and gut. In a group of healthy volunteers the investigators will determine normal values in ambient temperature and after cooling of an extremity. Another group of patients after cardiac surgery, where usually a poor tissue perfusion without metabolic failure is present will serve as another "control" population in their post-surgery stabilization period. The values from healthy volunteers and cardiac surgery patients will be compared to those of patients in septic shock.

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Study Start: 2016-07-13
• Primary Completion: 2017-03-28
• Study Completion: 2017-03-28
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients rewarming after cardiac surgery	Peripheral Perfusion index by Carescape Patientenmonitor	measurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until extubation
healthy volunteers	Peripheral Perfusion index by Carescape Patientenmonitor	measurements of peripheral perfusion including capillary refill time and peripheral perfusion index in ambient temperature and after cooling of extremity
septic shock patients	Peripheral Perfusion index by Carescape Patientenmonitor	measurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until normalisation of lactate sonographic assesment of perfusion of solid organs once within 24h after admission

Primary Outcome Measures

Name	Time	Method
peripheral perfusion index	measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)	PPI in healthy controls, septic shock patients and patients rewarming after cardiac surgery

Secondary Outcome Measures

Name	Time	Method
capillary refill time	measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)	CRT in healthy controls, septic shock patients and patients rewarming after cardiac surgery

Trial Locations

Locations (1)

Bern University Hospital; 🇨🇭 Bern, Switzerland