New Method for Real-time Detection of Tissue Ischemia (ISCALERT)

NCT04879875 | Completed

• 1 other identifier: 1-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for limb (arm/leg) surgery with tourniquet. IscAlert is measuring CO2 in muscular and subcutaneous tissue. IscAlert is inserted into normal muscle and subcutaneous tissue in ischemic (operated limb with a tourniquet) and non-ischemic limb (non-operated limb).After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in CO2, which will be detected by the sensors on the operated extremity, while the sensors on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the CO2 level is expected to decrease into normal levels. 50 number of patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlert™ will be inserted for 72 hours in the operated extremity after the end of surgery. After this, the sensors are removed. 250 Devices is planned to be used in this clinical study.

Conditions

Ischemia; Blood Circulation Disorder; Carbon Dioxide; Biosensing Techniques

Keywords

Ischemia; Carbon dioxide; Biosensor; Musculature; Subcutaneous; Surgery; Orthopedic; Limb

Outcome Measures

Primary Outcomes (1)

• Tissue CO2-level

  Tissue CO2-level (kPa) during insertion periode

  72 hours

Secondary Outcomes (13)

• Bleeding

  72 hours

• Infection

  30 days

• Pain score at insertion site - Numerical Rating Scale (NRS) - 30 days after discharge from hospital

  30 days

• Pain score at insertion site - Numerical Rating Scale (NRS) - 7 days after discharge from hospital

  7 days

• Arterial CO2 level

  3 hours

Study Arms (2)

Group 1

EXPERIMENTAL

Patients scheduled for limb (arm/leg) surgery with tourniquet where IscAlert is removed immediately after surgery. All patients will receive 3 sensors in the limb undergoing surgery and two control sensors in the opposite limb. The sensor in the opposite extremity which is not to be operated serves as a reference value for CO2.

Device: IscAlert

Group 2

EXPERIMENTAL

Patients scheduled for limb (arm/leg) surgery with tourniquet where IscAlert is removed 72 hours after surgery. All patients will receive 3 sensors in the limb undergoing surgery and two control sensors in the opposite limb. The sensor in the opposite extremity which is not to be operated serves as a reference value for CO2.

Device: IscAlert 72h

Interventions

IscAlert DEVICE

3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed after end of surgery.

Group 1

IscAlert 72h DEVICE

3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed 72 hours after end of surgery

Group 2

Eligibility Criteria

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

You may qualify if:

• Patients must be scheduled for orthopedic limb surgery with planned use of tourniquet.
• Subject must be ≥ 18 years
• Able to give written signed informed consent
• Tourniquet planned to be used \> 30 minutes

You may not qualify if:

• Sign of inflammation/infection, hematoma, and traumatized tissue at insertion site

Sponsors & Collaborators

• Oslo University Hospital: lead
• European Commission: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Magne Røkkum, Ph.d.

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Orthopaedic Department/Professor

Model Details: Prospective, Cohort

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 10, 2021
• Study Start: September 1, 2021
• Primary Completion: July 24, 2022
• Study Completion: July 24, 2022
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)