Perfusion; ComplicationsNCT04081974
Prevalence and Predictors of Distal Limb Ischemia in Minimally Invasive Cardiac Surgery.
An observational study of Perfusion; Complications, run by Jessa Hospital at 1 site in Belgium.
Trial summary
Peripheral arterial cannulation is a necessity for installation of cardiopulmonary bypass in minimally invasive cardiac surgery (MICS). In the vast majority of cases, the femoral artery is the preferred arterial cannulation site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perfusion; Complications
- What is being tested?
- Distal leg perfusion
- How many people
- 280 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Nov 2019to 27 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients presenting for minimally invasive cardiac surgery will be screened for participation to the study. Eligible participants fulfill all inclusion criteria and no exclusion criteria.
Who may be able to join
- 1. Patients undergoing minimally invasive cardiac surgery older than 18 years.
Who cannot join
- History of leg amputation.
- Calf muscle atrophy due to neuromuscular disorder or muscle diseases.
- Stanford type A aortic dissection.
- BMI > 40.
- Allergy for NIRS electrode.
- Revision surgery < 72h after primary surgery.
- Postoperative need for intra-aortic balloon pump and/or ECMO.
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral arterial cannulation is a necessity for installation of cardiopulmonary bypass in minimally invasive cardiac surgery (MICS). In the vast majority of cases, the femoral artery is the preferred arterial cannulation site. Distal limb hypoperfusion and ischemia can occur in the cannulated limb since antegrade perfusion is not routinely provided. Furthermore, the diameter of the cannula required to maintain adequate cardiopulmonary bypass (CPB) flow is often approaching that of the patient's femoral artery diameter, compromising distal blood flow. The possibility of distal limb ischemia is often raised as a criticism to peripheral cannulation for cardiopulmonary bypass and by extent to minimally invasive cardiac surgery. Ischemia of the lower limb is of high incidence in patients undergoing extracorporeal membrane oxygenation (ECMO) therapy, in which the same femoral cannulation technique is used. Therefore this complication has extensively been described in ECMO literature. However, no clinical trials have been performed in patients undergoing MICS, despite the same cannulation and perfusion route. ECMO patients often differ from MICS patients in morbidity as well as in duration of cannulation. Up to now, one could not observe any clinical sequelae of limb ischemia in MICS patients but a formal study of distal leg perfusion in MICS is recommended to screen its safety and to identify possible risk factors.
Read the detailed description
Study design and setting Single-center prospective observational cohort study in patients undergoing minimally invasive cardiac surgery with peripheral arterial cannulation. This is the standard of care in the institution of the investigators.
Population All consecutive patients presenting for minimally invasive cardiac surgery will be screened for participation to the study. Eligible participants fulfill all inclusion criteria and no exclusion criteria (described below in more detail).
NIRS Near infrared spectroscopy (NIRS) is currently accepted as the golden standard monitoring tool for tissue oxygenation and for early detection of ischemia. The NIRS measures and displays a percent regional oxygenation saturation (rSO2). This value quantifies the percentage of regional hemoglobin oxygen saturation. It is measured by an electrode placed on the skin, and is therefore totally non-invasive. NIRS originally has been used to measure brain saturation, but its indications have been extended to any region of interest. Multiple studies validated NIRS as a useful monitor for detection of ischemia of the lower extremities in various settings (ECMO patients, patients with peripherally vascular disease). Patton-Rivera at al. showed rSO2 differentials > 15% had a 100% sensitivity and specificity for the detection of clinically markable hypoperfusion of the cannulated leg in ECMO patients.
Data collection Patient demographics and medical history will be collected together with the EuroScore II i.e the estimated risk of in-hospital death after cardiac surgery. NIRS values will be coded and anonymously recorded onto a Universal Serial Bus (USB) device and saved on a pc with limited access. rSO2 differentials between the cannulated and non-cannulated leg and Tissue Oxygenation Index (TOI) differentials from baseline in the cannulated leg will be noted (%). After completion and publication of the study all data will be deleted from the device.
Data for analyses of variables will be extracted from the anesthetic and perfusion charts. These charts are stored in the patients individual record.
Interventions On arrival in the operating room, oximeter pads of a NIRO-200NX (NIRO,Hamamatsu® , Japan) NIRS monitor will be placed on the muscles of the calf bilaterally. Lower extremity NIRS is an added monitoring tool as it is currently not being used in our institutional clinical management. Neither anesthetic nor surgical plans will be altered by the study and are left to the discretion of the attending consultant. Also, perfusion goals may not be altered to the results of the leg NIRS. Therefore, the NIRS display will be covered in the operating room throughout the surgery.
- Conditions
- Perfusion; Complications
- Being tested
- Distal leg perfusion
- Keywords
- Minimally invasive cardiac surgery, Distal limb perfusion, Ischemia
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal leg perfusionOther
On arrival in the operating room, oximeter pads of a NIRO-200NX (NIRO,Hamamatsu® , Japan) NIRS monitor will be placed on the muscles of the calf bilaterally. Lower extremity NIRS is an added monitoring tool as it is currently not being used in our institutional clinical management. Neither anesthetic nor surgical plans will be altered by the study and are left to the discretion of the attending consultant. Also, perfusion goals may not be altered to the results of the leg NIRS. Therefore, the NIRS display will be covered in the operating room throughout the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive cardiac surgery | All consecutive patients presenting for minimally invasive cardiac surgery will be screened for participation to the study. Receives: Other: Distal leg perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop of 15% in regional oxygen saturation (rSO2) lasting 4 minutes or longer between the cannulated and non-cannulated limb
A drop of 15% or more in StO2 for ≥ 4 minutes between the cannulated and non-cannulated leg during the cannulation period
Measured: Duration of the surgery
Secondary outcomes (4)
Difference in tissue oxygenation index (TOI) compared to baseline
A TOI shift below 50% from baseline in the cannulated leg
Measured: Duration of the surgery
Identification of predictors of poor distal perfusion in the cannulated limb
Seven variables will be analyzed for correlation with elevated StO2 differentials to identify risk factors for distal limb ischemia after peripheral cannulation for CPB: Patient age, Patient sex, Previous artery disease, Type of surgery (coronary artery bypass graft vs valve surgery),Arterial cannula size, Duration of cannulation, Body Surface Area
Measured: from surgery until 6 months after surgery
Peripheral vascular surgery
Prevalence of peripheral vascular surgery within six months after cardiac surgery (telephonic follow-up after 6 months and revision of patients medical record)
Measured: 6 months after surgery
Relationship between distal limb ischemia and acute kidney injury
Investigate a possible relationship between distal limb ischemia and acute kidney injury
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start25 Nov 2019
- Primary completion27 Jan 2021
- Study completion27 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion; ComplicationsStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081974
- Sponsor's protocol ID
- Leg perfusion
- Status last verified
- Jun 2022
- First submitted
- 2 Sep 2019
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictors of Distal Limb Ischemia in Minimally Invasive Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT04081974
- Acronym / sponsor ID
- Leg perfusion
- Conditions
- Perfusion; Complications
- Keywords
- Minimally invasive cardiac surgery, Distal limb perfusion, Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jun 2021 (actual)
- First posted
- 9 Sep 2019 (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.
Peripheral arterial cannulation is a necessity for installation of cardiopulmonary bypass in minimally invasive cardiac surgery (MICS). In the vast majority of cases, the femoral artery is the preferred arterial cannulation site. Distal limb hypoperfusion and ischemia can occur in the cannulated limb since antegrade perfusion is not routinely provided. Furthermore, the diameter of the cannula required to maintain adequate cardiopulmonary bypass (CPB) flow is often approaching that of the patient's femoral artery diameter, compromising distal blood flow. The possibility of distal limb ischemia is often raised as a criticism to peripheral cannulation for cardiopulmonary bypass and by extent to minimally invasive cardiac surgery. Ischemia of the lower limb is of high incidence in patients undergoing extracorporeal membrane oxygenation (ECMO) therapy, in which the same femoral cannulation technique is used. Therefore this complication has extensively been described in ECMO literature. However, no clinical trials have been performed in patients undergoing MICS, despite the same cannulation and perfusion route. ECMO patients often differ from MICS patients in morbidity as well as in duration of cannulation. Up to now, one could not observe any clinical sequelae of limb ischemia in MICS patients but a formal study of distal leg perfusion in MICS is recommended to screen its safety and to identify possible risk factors.
Detailed description
Study design and setting Single-center prospective observational cohort study in patients undergoing minimally invasive cardiac surgery with peripheral arterial cannulation. This is the standard of care in the institution of the investigators.
Population All consecutive patients presenting for minimally invasive cardiac surgery will be screened for participation to the study. Eligible participants fulfill all inclusion criteria and no exclusion criteria (described below in more detail).
NIRS Near infrared spectroscopy (NIRS) is currently accepted as the golden standard monitoring tool for tissue oxygenation and for early detection of ischemia. The NIRS measures and displays a percent regional oxygenation saturation (rSO2). This value quantifies the percentage of regional hemoglobin oxygen saturation. It is measured by an electrode placed on the skin, and is therefore totally non-invasive. NIRS originally has been used to measure brain saturation, but its indications have been extended to any region of interest. Multiple studies validated NIRS as a useful monitor for detection of ischemia of the lower extremities in various settings (ECMO patients, patients with peripherally vascular disease). Patton-Rivera at al. showed rSO2 differentials > 15% had a 100% sensitivity and specificity for the detection of clinically markable hypoperfusion of the cannulated leg in ECMO patients.
Data collection Patient demographics and medical history will be collected together with the EuroScore II i.e the estimated risk of in-hospital death after cardiac surgery. NIRS values will be coded and anonymously recorded onto a Universal Serial Bus (USB) device and saved on a pc with limited access. rSO2 differentials between the cannulated and non-cannulated leg and Tissue Oxygenation Index (TOI) differentials from baseline in the cannulated leg will be noted (%). After completion and publication of the study all data will be deleted from the device.
Data for analyses of variables will be extracted from the anesthetic and perfusion charts. These charts are stored in the patients individual record.
Interventions On arrival in the operating room, oximeter pads of a NIRO-200NX (NIRO,Hamamatsu® , Japan) NIRS monitor will be placed on the muscles of the calf bilaterally. Lower extremity NIRS is an added monitoring tool as it is currently not being used in our institutional clinical management. Neither anesthetic nor surgical plans will be altered by the study and are left to the discretion of the attending consultant. Also, perfusion goals may not be altered to the results of the leg NIRS. Therefore, the NIRS display will be covered in the operating room throughout the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive cardiac surgery | – | Other: Distal leg perfusionAll consecutive patients presenting for minimally invasive cardiac surgery will be screened for participation to the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients presenting for minimally invasive cardiac surgery will be screened for participation to the study. Eligible participants fulfill all inclusion criteria and no exclusion criteria.
Key inclusion criteria (1 listed)
- 1. Patients undergoing minimally invasive cardiac surgery older than 18 years.
Key exclusion criteria (7 listed)
- History of leg amputation.
- Calf muscle atrophy due to neuromuscular disorder or muscle diseases.
- Stanford type A aortic dissection.
- BMI > 40.
- Allergy for NIRS electrode.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal leg perfusionOn arrival in the operating room, oximeter pads of a NIRO-200NX (NIRO,Hamamatsu® , Japan) NIRS monitor will be placed on the muscles of the calf bilaterally. Lower extremity NIRS is an added monitoring tool as it is currently not being used in our institutional clinical management. Neither anesthetic nor surgical plans will be altered by the study and are left to the discretion of the attending consultant. Also, perfusion goals may not be altered to the results of the leg NIRS. Therefore, the NIRS display will be covered in the operating room throughout the surgery. | Other | Minimally invasive cardiac surgery |
Primary outcome
Drop of 15% in regional oxygen saturation (rSO2) lasting 4 minutes or longer between the cannulated and non-cannulated limb
Time frame: Duration of the surgery
A drop of 15% or more in StO2 for ≥ 4 minutes between the cannulated and non-cannulated leg during the cannulation period
4 secondary outcomes
Difference in tissue oxygenation index (TOI) compared to baseline
Time frame: Duration of the surgery
Identification of predictors of poor distal perfusion in the cannulated limb
Time frame: from surgery until 6 months after surgery
Peripheral vascular surgery
Time frame: 6 months after surgery
Relationship between distal limb ischemia and acute kidney injury
Time frame: through study completion, an average of 6 months
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 7 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Perfusion; Complications, run by Jessa Hospital at 1 site in Belgium.
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 1 inclusion and 7 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 7 Jun 2022. 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 Belgium. 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?
Drop of 15% in regional oxygen saturation (rSO2) lasting 4 minutes or longer between the cannulated and non-cannulated limb (time frame: Duration of the surgery). 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 7 Jun 2022.