Groin Complications in Open Vs. Percutaneous Peripheral Cannulation in Minimally Invasive Cardiac Surgery (ProGlide-II)

Jessa Hospital

Status: Withdrawn

Conditions: Cardiovascular Diseases

Treatments: Procedure: Percutaneous cannulation; Procedure: Open cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05598385

2022/148

Details and patient eligibility

About

The aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery

Full description

The femoral artery (FA) and vein (FV) are considered the preferred site for peripheral cannulation during cardiac surgery. Normally, a small incision is made to access the FA and FV, which is also called open surgical cannulation. Afterwards, the incision site is traditionally closed with sutures (1, 2). However, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3).

Recently, suture-mediated closure systems (SMCS) have been developed to achieve hemostasis (4). This allows for percutaneous cannulation. Still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. Therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years
• Patients undergoing elective endoscopic cardiac surgery

Exclusion criteria

• Patients that do no understand Dutch, French, or English
• Heavily calcified cannula introduction site
• Central cannulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Percutaneous cannulation

Active Comparator group

Description:

Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.

Treatment:

Procedure: Percutaneous cannulation

Open cannulation

Active Comparator group

Description:

Open peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.

Treatment:

Procedure: Open cannulation