Prevalence and Predictors of Distal Limb Ischemia in Minimally Invasive Cardiac Surgery.

NCT04081974 | Completed DMC

• 1 other identifier: Leg perfusion
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Perfusion; Complications

Keywords

Minimally invasive cardiac surgery; Distal limb perfusion; Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

  Duration of the surgery

Secondary Outcomes (4)

• Difference in tissue oxygenation index (TOI) compared to baseline

  Duration of the surgery

• Identification of predictors of poor distal perfusion in the cannulated limb

  from surgery until 6 months after surgery

• Peripheral vascular surgery

  6 months after surgery

• Relationship between distal limb ischemia and acute kidney injury

  through study completion, an average of 6 months

Study Arms (1)

Minimally invasive cardiac surgery

All consecutive patients presenting for minimally invasive cardiac surgery will be screened for participation to the study.

Other: Distal leg perfusion

Interventions

Distal leg perfusion OTHER

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.

Minimally invasive cardiac surgery

Eligibility Criteria

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

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.

You may qualify if:

• \. Patients undergoing minimally invasive cardiac surgery older than 18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care

Hasselt, Belgium

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist, MD, PhD

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 9, 2019
• Study Start: November 25, 2019
• Primary Completion: January 27, 2021
• Study Completion: June 27, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)