Open AccessA randomized controlled trial comparing controlled reoxygenation and standard cardiopulmonary bypass in paediatric cardiac surgery
Author(s) -
Massimo Caputo,
Lauren J Scott,
Toity Deave,
Lucy Dabner,
Andrew Parry,
Gianni Angelini,
Karen Sheehan,
Șerban Stoica,
Lucy Ellis,
Rosie A Harris,
Chris Rogers
Publication year - 2020
Publication title -
european journal of cardio-thoracic surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 133
eISSN - 1873-734X
pISSN - 1010-7940
DOI - 10.1093/ejcts/ezaa318
Subject(s) - medicine , cardiopulmonary bypass , hazard ratio , anesthesia , randomized controlled trial , confidence interval , intubation , intensive care unit , adverse effect , cardiac surgery , clinical endpoint , inotrope , creatinine , surgery , cardiology
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.