A randomised controlled trial investigating carbon dioxide insufflation of the pericardial field as a neuroprotective strategy in open chamber cardiac surgery.

A randomised controlled trial investigating the effect of carbon dioxide insufflation of the pericardial field as a neuroprotective strategy to decrease postoperative neurocognitive impairment in patients undergoing open chamber cardiac surgery.'

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000844246

Enrollment

140

Registered

2009-09-30

Start date

2009-11-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpse of the study is to determine if blowing carbon dioxide gas into the chest cavity during a cardiac surgery operation involving the heart valves protects against the decrease in mental function that occurs following these operations.

Interventions

Carbon dioxide insufflation of the pericardial field intraoperatively which involves blowing carbon dioxide gas into the chest cavity only during the cardiac surgery operation via a tube. It will be continuously insufflated at 10 Litre/minute from the opening of the cardiac chamber until the closure of the cardiac chamber. This tube is connected to a device called CarbonAid gas diffuser device (K052125)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Undergoing an open cardiac (aortic and/or mitral valve) operation; competence to provide informed consent;ability to communicate in English to undertake the neuropsychological test

Exclusion criteria

Past history of cerebrovascular accident (stroke or Transient Ischemic Attack (TIA));history of clinically diagnosed active psychiatric conditions; emergency or salvage cardiac valve operations; Intelligence Quotient < 70

Outcome results