HELIox CardiOPlegia Trial During Cardiac surgERy (HELICOPTER-1)

Unity Health Toronto

Status: Unknown

Conditions: C.Surgical Procedure; Cardiac

Treatments: Other: Standard of care; Other: Heliox

Study type: Interventional

Funder types: Other

Identifiers

NCT02745951

15 - 311

Details and patient eligibility

About

The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of administering Heliox in cardioplegia during cardiac surgery and whether it has the potential to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.

Full description

The HELICOPTER-1 Trial is a single centre, randomized trial evaluating the feasibility of administration of Heliox for prevention of myocardial ischemia in patients undergoing cardiac surgery. Half of the study population will be randomly assigned to the receive cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture, while the other half will be randomized to receive the current clinical standard of care (nitrogen and oxygen in cardioplegia).

Subjects will be followed up daily during their post-operative course in hospital for clinical outcomes. A 30-day phone follow-up will be conducted for vital status and MI.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Cardiac surgery with CPB where use of a coronary sinus catheter is indicated

Exclusion criteria

• Patient refusal
• Recent myocardial infarction (less than 7 days old)
• Left ventricular ejection fraction less than 30%
• Known pregnancy on date of surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Heliox

Experimental group

Description:

Cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture while the patient is on cardiopulmonary bypass

Treatment:

Other: Heliox

Standard of care

Active Comparator group

Description:

Cardioplegia enriched with a Nitrogen and Oxygen mixture while the patient is on cardiopulmonary bypass

Treatment:

Other: Standard of care