None listed
Conditions
Brief summary
Neurological complications are common and occur in 32 to 83% of patients that have undergone cardiac surgery. This clinical outcome is believed to be due to the presence of gas, which enters the blood stream to the brain when the patient comes off the cardio pulmonary bypass machine, and may persist for up to 5 years. In addition to temporary neurocognitive effects, gas in the bloodstream can also cause permanent neurological defects and life threatening arrhythmia's. To avoid these consequenses several deairing techniques are used, one of which is the flooding of the chest cavity with Carbon Dioxide, an inert gas that is easily absorbed by the body, to minimize the gas bubbles in the bloodstream. We believe that the humidification of the Carbon Dioxide used to fill the chest cavity will further improve deairing by making the gas easier for the body to be absorbed. In a previous study there was a benefit to heating and humidifying the Carbon Dioxide used to deair. It reduced the time it took to deair the heart from 16 minutes to 2 minutes, reduced the percentage of patients that had gas bubbles from 70% to 24% and the number of patients that showed neurological symptoms from 29% to 2%. In this trial we aim to assess the impact of heating and humidifying the Carbon Dioxide used to fill the chest cavity on the number of gas bubbles after deairing and whether as a consequence will reduce the neurological complications. Further we hope to develop a method of objectively measuring the amount of bubbles in the blood.
Interventions
This is a blinded randomized controlled, prospective trial in patients undergoing aortic or mitral valve replacement or repair requiring cardiopulmonary bypass. Subjects will be randomly allocated to one of three groups.
• Group 1: Dry CO2 insufflation (Bone dry, 21 degrees Celsius)
• Group 2: Warm humidified CO2 insufflation (37 degrees celsius, 98% relative humidity)
• Group 3: Ambient air
For the duration of the surgery patients in the dry CO2 insufflation group will have bone dry room temper
This is a blinded randomized controlled, prospective trial in patients undergoing aortic or mitral valve replacement or repair requiring cardiopulmonary bypass. Subjects will be randomly allocated to one of three groups. • Group 1: Dry CO2 insufflation (Bone dry, 21 degrees Celsius) • Group 2: Warm humidified CO2 insufflation (37 degrees celsius, 98% relative humidity) • Group 3: Ambient air For the duration of the surgery patients in the dry CO2 insufflation group will have bone dry room temperature CO2 insufflated into their thorax, similarly the warm humidified CO2 group will have humidified normothermic CO2 insufflated into their thorax, and the ambient air group will not be insuflated and left open to ambient room air. Participants, surgeon, anaesthetist will be blinded to their allocation. The perfusionist will remain un-blinded and be responsible for delivering CO2 and turning the HumiGard™ system on or off depending on what group the patient is allocated to. HumiGard™ system: • F&P HumiGard™ MR870AEU surgical humidifier • F&P HumiGard™ ST320 Surgical Humidification Kit • ST300DF VITA-diffuser® Cardia Innovation • 900ST100 Adapter The intervention is complete at end of surgery, the performance of the HumiGard machine has been validated as per FDA and MEDDEF requirements
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for aortic valve replacement or repair and/or a mitral valve replacement or repair, will be included in the study. 2. Able to give informed consent 3. Male or female, 18 - 85 years of age
Exclusion criteria
1. Significant diagnosed and documented chronic obstructive pulmonary disease/emphysema 2. Significant (>50%) carotid artery disease 3. Prior cardiac or pulmonary surgery 4. Thoracic trauma 5. At anaesthetist discretion on ability to compensate for CO2
Outcome results
None listed