Lower Limb IschemiaINVOHVNCT04533035
Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation
An observational study of Lower Limb Ischemia, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Limb Ischemia
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 28 Aug 2020to 26 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Operative hallux valgus patients in Kuopio University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lower Limb Ischemia
- Keywords
- NIRS Spectroscopy, Lower Limb, Ischemia, Adults
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | 30 patients undergoing hallux valgus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes from tourniquet application
Secondary outcomes (2)
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
Measured: 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.
The percentual increase of the regional oxygen saturation in the lower limbs due to the induction of a spinal anesthesia.
10% increase in NIRS value after 30 minutes after spinal anesthesia induction
Measured: 30 minutes from induction of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start28 Aug 2020
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Govenius, Kuopio University Hospital
- Investigators
- Kimmo Mäkinen, docent, Study director, Kuopio University HospitalAnna H Govenius, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533035
- Sponsor's protocol ID
- 5101143
- Acronym
- INVOHV
- Status last verified
- Mar 2021
- First submitted
- 20 Aug 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation
- ClinicalTrials.gov ID
- NCT04533035
- Acronym / sponsor ID
- INVOHV / 5101143
- Conditions
- Lower Limb Ischemia
- Keywords
- NIRS Spectroscopy, Lower Limb, Ischemia, Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort | – | –30 patients undergoing hallux valgus surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Operative hallux valgus patients in Kuopio University Hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentual decrease of the regional oxygen saturation in the lower limb 15 minutes after the tourniquet is applied.
Time frame: 15 minutes from tourniquet application
50% decrease from baseline NIRS value in 15 minutes
2 secondary outcomes
The time that the regional oxygen saturation in the lower limb takes to recover after the tourniquet is released.
Time frame: 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.
The percentual increase of the regional oxygen saturation in the lower limbs due to the induction of a spinal anesthesia.
Time frame: 30 minutes from induction of spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimmo Mäkinen, docent study director
Kuopio University Hospital
Anna H Govenius, MD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Ischemia, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentual decrease of the regional oxygen saturation in the lower limb 15 minutes after the tourniquet is applied. (time frame: 15 minutes from tourniquet application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.