New Method for Real-time Detection of Tissue Ischemia

NCT04893473 | Withdrawn

• 1 other identifier: 1-20
• Study Type: observational
• Target: N/A
• 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 carbon dioxide 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 carbon dioxide, which will be detected by the sensor on the operated extremity, while the sensor on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the carbon dioxide 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 carbon dioxide level

  Tissue carbon dioxide level (kPa) during insertion period

  72 hours

Secondary Outcomes (8)

• Bleeding

  72 hours

• Infection

  1 week

• Arterial carbon dioxide level

  2 hours

• Arterial lactate level

  2 hours

• Arterial pH level

  2 hours

Study Arms (2)

Group 1

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 carbon dioxide.

Device: IscAlert

Group 2

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 carbon dioxide.

Device: IscAlert

Interventions

IscAlert DEVICE

3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and carbon dioxide is measured continuously.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who need limb surgery with tourniquet cuff

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
• Chronic use of anticoagulants

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, Md, Ph.d

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: May 19, 2021
• Study Start: May 14, 2021
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)