Recruiting

Heliox

Sponsor:

Unity Health Toronto

Code:

NCT02745951

Conditions

C.Surgical Procedure; Cardiac

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heliox

Standard of care

Study Details

Brief summary:

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.

Conditions

C.Surgical Procedure; Cardiac

Study ID

NCT02745951

Start date

Apr, 2016

Status verified date

Apr, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Heliox

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

active comparator: Standard of care

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

Interventions

Heliox

Half of the study population will be randomly assigned to receive cardioplegia enriched with a 70:30 (Helium:Oxygen) via a D100 pediatric oxygenator. The Heliox itself will need to be administered via an oxygen regulator using a low flowmeter.

Standard of care

The other half will be randomized to Nitrogen:Oxygen mixture. This will be done through the standard of care cardioplegia apparatus. There will be no novel interventions administered in this group.

Primary outcome measure

  • Feasibility of using Heliox to oxygenate the blood cardioplegia [ Time Frame: 30 days from the intervention ]

Central Contacts and Locations

Central contacts

David Mazer, MD

416-864-5825mazerd@smh.ca

Constantine Dalamagas, RRT, CPC

416-864-6060DalamagasC@smh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Constantine Dalamagas, RRT, CPC

416-864-6060DalamagasC@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

May 3, 2016

Last verified

Apr, 2016

Keywords

  • cardiopulmonary bypass
  • cardioplegia
  • cardioprotection
  • coronary artery bypass graft surgery
  • heliox

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2016-05-03.