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HELIox CardiOPlegia Trial During Cardiac surgERy

NCT02745951 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-05-03

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • David Mazer, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02745951 on ClinicalTrials.gov