Lower Limb Tissue Oxygenation Using Near-infrared Spectro... | NCT04533035

Studies
Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation

NCT04533035

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

Mar 2, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Lower Limb Ischemia

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2020Actual

Primary Completion Date

Feb 26, 2021Actual

Completion Date

Feb 26, 2021Actual

First Submitted Date

Aug 20, 2020

First Submission Date that Met QC Criteria

Aug 26, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anna Govenius, Specialist in cardiothoracic surgery, MD, Kuopio University HospitalPrincipal Investigator

Lead Sponsor

Kuopio University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In acute lower limb ischemia the main goal of the treatment is to restore the blood before irreversible damage to the soft tissues of the limb. Delays in identifying acute lower limb ischemia may lead to limb loss or lead to the loss of the patient. Situations in which the patient is unable to express symptoms of the acute lower limb ischemia, such as during general anesthesia, in intensive care, or immediately after vascular surgery, are challenging for medical staff to identify. A reliable, easy-to-use and non-invasive monitoring method is not yet in every day use. The aim of this study is to demonstrate that Near InfraRed Spectroscopy (NIRS) monitoring is such a monitoring method.

Tourniquet induced ischemia is often used in hallux valgus surgery because it offers a bloodless view of the anatomical structures. In our study we will measure the soft tissue perfusion (rSO2) of the lower limbs during the whole operation. The sensors based on near-infrared spectroscopy will be located to the tibial surface and will record the normal state before the start of the tourniquet, during the tourniquet and also in the recovery phase.

The hypothesis is that rSO2 decreases linearly as a function of time from the beginning of the tourniquet induced ischemia and the recovery time depends on the duration of the tourniquet. In our study the patients will be operated under a spinal anesthesia. We also hypothesise that rSO2 increases due to the induction of the spinal anesthesia. Our goal is to define the percentual decline of rSO2 that is significant for lower limb ischemia and also its time response to induction of ischemia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Single cohort		30 patients undergoing hallux valgus surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentual decrease of the regional oxygen saturation in the lower limb 15 minutes after the tourniquet is applied.	50% decrease from baseline NIRS value in 15 minutes	15 minutes from tourniquet application

Secondary Outcomes

Measure	Description	Time Frame
The time that the regional oxygen saturation in the lower limb takes to recover after the tourniquet is released.	The time to NIRS value to reach baseline value after tourniquet is released	From the moment tourniquet is released to the point that NIRS value reaches it's baseline or patient is mobilised in the recovery room, whichever came first, assessed up to two hours.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient understands the meaning of the study and related measures.
Patient gives his or her written informed consent.
A tourniquet is used.
The procedure is performed under spinal anesthesia.
Body mass index under 40.

Exclusion Criteria:

Patient belongs to any of the following special groups: disabled people, minor, pregnant or breast feeding women, convicts, forensic psychiatric patients.
Previous lower limb vascular surgery.
Previous lower limb deep vein thrombosis.
Previously performed tibial fasciotomies.
Any another reason why the researcher considers that the patient is not suitable for the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Operative hallux valgus patients in Kuopio University Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kimmo Mäkinen, docent	Kuopio University Hospital	Study Director
Anna H Govenius, MD	Kuopio University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio		70100	Finland

Condition Browse Module

MeSH Terms

ID	Term
D007511	Ischemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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