None listed
Conditions
Brief summary
We hypothesised that adding nitric oxide to the cardiopulmonary bypass circuit may reduce the occurrence of low cardiac output syndrome on ICU and improve patient outcomes (such as reducing the need for mechanical ventilation and shorten ICU length of stay)
Interventions
Nitric Oxide was blended with oxygen in the gas administration line to the cpb (cardiopulmonary bypass) circuit, for the duration of cpb which was dependent on procedure (range 30 to 240 mins).
Nitric oxide was delivered at 20 parts per million (Ikaria delivery system which measures concentration of nitric oxide delivery electrochemically)
Methaemoglobin levels were monitored throughout cpb by the study perfusionist (who was unblinded to whether nitric oxide was to be delivered). Levels were hig
Nitric Oxide was blended with oxygen in the gas administration line to the cpb (cardiopulmonary bypass) circuit, for the duration of cpb which was dependent on procedure (range 30 to 240 mins). Nitric oxide was delivered at 20 parts per million (Ikaria delivery system which measures concentration of nitric oxide delivery electrochemically) Methaemoglobin levels were monitored throughout cpb by the study perfusionist (who was unblinded to whether nitric oxide was to be delivered). Levels were higher in those that received nitric oxide (proving adherence - nitric oxide was indeed being delivered) but never reached clinically important levels.
Sponsors
Intensive Care Unit, Royal Childrens' Hospital, Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
any child undergoing cpb for congenital heart disease
Exclusion criteria
emergency cases children requiring inhaled nitric oxide prior to surgery
Outcome results
None listed