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Randomized Controlled Trial
. 2021 Jan 29;59(2):349-358.
doi: 10.1093/ejcts/ezaa318.

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

Massimo Caputo  1   2 , Lauren J Scott  3 , Toity Deave  4 , Lucy Dabner  3 , Andrew Parry  1 , Gianni D Angelini  2 , Karen Sheehan  1 , Serban Stoica  1 , Lucy Ellis  3 , Rosie Harris  3 , Chris A Rogers  3
Affiliations
Randomized Controlled Trial

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

Massimo Caputo et al. Eur J Cardiothorac Surg. .

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.

Keywords: Cardiopulmonary bypass; Clinical trials; Controlled reoxygenation; Cyanosis.

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Figures

Figure 1:
Figure 1:
Flow of participants.
Figure 2:
Figure 2:
Primary outcome results. Numbers in brackets are the 95% confidence interval. GMR: geometric mean ratio; HR: hazard ratio; ICU: intensive care unit.
Figure 3:
Figure 3:
Secondary outcome results. Numbers in brackets are the 95% confidence interval. Oxic-2 trial only. GMR: geometric mean ratio; OR: odds ratio.
Figure 4:
Figure 4:
PO2 levels over time. Treatment estimates (95% CI): 10 min post start CPB GMR = 0.54 (0.43–0.68), 30 min post start CPB GMR = 0.93 (0.77–1.12), 10 min post end CPB GMR = 0.92 (0.63–1.35), 2 h in PICU GMR = 1.10 (0.81–1.48), 6 h in PICU GMR = 1.03 (0.78–1.37) and 24 h in PICU GMR = 1.07 (0.79–1.45). Oxic-2 trial only. CI: confidence interval, CPB: cardiopulmonary bypass; GMR: geometric mean ratio; PICU: paediatric intensive care unit; PO2: partial pressure of oxygen.
Figure 5:
Figure 5:
(A) Creatinine levels over time. Treatment estimates [95% confidence interval (CI)]: day 1 GMR = 0.95 (0.83–1.10), day 2 GMR = 0.86 (0.75–1.00), day 3 GMR = 0.93 (0.80–1.08), day 4 GMR = 1.03 (0.89–1.20) and day 5 GMR = 1.02 (0.86–1.19). Oxic-2 trial only. (B) Urea levels over time. Numbers in brackets are the 95% CI. Oxic-2 trial only. GMR: geometric mean ratio.
Figure 6:
Figure 6:
Bayley developmental assessment composite scores. Oxic-2 trial only. CI: confidence interval; MD: mean difference.
None
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References

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