A randomized controlled trial comparing controlled reoxygenation and standard cardiopulmonary bypass in paediatric cardiac surgery

Massimo Caputo*, Lauren J Scott, Toity Deave, Lucy Dabner, Andrew Parry, Gianni D Angelini, Karen Sheehan, Serban Stoica, Lucy Ellis, Rosie Harris, Chris A Rogers

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

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Abstract

OBJECTIVES: Controlled reoxygenation on starting cardiopulmonary bypass (CPB) rather than hyperoxic CPB may confer clinical advantages during surgery for congenital cyanotic heart disease.

METHODS: A single-centre, randomized controlled trial was carried out to compare the effectiveness of controlled reoxygenation (normoxia) versus hyperoxic CPB in children with congenital cyanotic heart disease undergoing open-heart surgery (Oxic-2). The co-primary clinical outcomes were duration of inotropic support, intubation time and postoperative intensive care unit (ICU) and hospital stay. Analysis of the primary outcomes included data from a previous trial (Oxic-1) conducted to the same protocol.

RESULTS: Ninety participants were recruited to Oxic-2 and 79 were recruited to the previous Oxic-1 trial. There were no significant differences between the groups for any of the co-primary outcomes: inotrope duration geometric mean ratio (normoxia/hyperoxic) 0.97, 95% confidence interval (CI) (0.69-1.37), P-value = 0.87; intubation time hazard ratio (HR) 1.03, 95% CI (0.74-1.42), P-value = 0.87; postoperative ICU stay HR 1.14 95% CI (0.77-1.67), P-value = 0.52, hospital stay HR 0.90, 95% CI (0.65-1.25), P-value = 0.53. Lower oxygen levels were successfully achieved during the operative period in the normoxic group. Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5. Childhood developmental outcomes were similar. In the year following surgery, 85 serious adverse events were reported (51 normoxic group and 34 hyperoxic group).

CONCLUSIONS: Controlled reoxygenation (normoxic) CPB is safe but with no evidence of a clinical advantage over hyperoxic CPB.

CLINICAL TRIAL REGISTRATION NUMBER: Current Controlled Trials-ISRCTN81773762.

Original languageEnglish
Article numberezaa318
Number of pages10
JournalEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery
Early online date30 Oct 2020
DOIs
Publication statusE-pub ahead of print - 30 Oct 2020

Structured keywords

  • Bristol Heart Institute

Keywords

  • cardiopulmonary bypass
  • cyanosis
  • controlled reoxygenation
  • clinical trials

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