Background
There is no consensus on the ventilation management during cardiopulmonary bypass (CPB), and the anesthesiologists or the surgeons usually ventilate the lungs with different ventilation strategies or keep them static. Better outcomes are more likely to occur when the ventilation is administered during CPB according to the existing literatures. However, the use of high fraction of inspired oxygen (FiO
2
) is debatable in cardiac surgery. And the potential effects of strategies combining low tidal volume (V
T
) ventilation with different FiO
2
during CPB on postoperative pulmonary complications (PPCs) are unclear.
Design
The VONTCPB trial is a single-center, prospective, double-blinded, randomized, controlled trial. We are going to recruit total 420 elective cardiac surgery patients with median sternotomy under CPB, who will be equally randomized into three different ventilation strategy groups: NoV, LOV and HOV. (1) The NoV group receives no mechanical ventilation during CPB; (2) the LOV group receives a low V
T
of 3-4 ml/kg of ideal body weight (IBW) with the respiratory rate (RR) of 10–12 acts/min, and the positive end-expiratory pressure (PEEP) of 5–8 cmH
2
O during CPB; the FiO
2
is 30%; (3) the HOV group receives a low V
T
of 3-4 ml/kg of IBW with the RR of 10–12 acts/min, and the PEEP of 5–8 cmH
2
O during CPB; the FiO
2
is 80%. The primary endpoints are the incidence of the composite of PPCs and the PPCs score. The secondary endpoints refer to the incidence of the oxygenation index (PaO
2
/FiO
2
ratio) < 300 mmHg at three time points (the moment arriving in the ICU, 6 and 12 h after arrival in the ICU), the surgical incision healing grade, the intubation time, the stay of ICU, the length of hospital stay, and mortality at 30 days after the surgery.
Discussion
The VONTCPB trial is the first study to assess the effects of strategies combining low tidal volume (V
T
) ventilation with different FiO
2
during CPB on patients’ outcomes.
Trial registration
ChiCTR1800015261
. Registered on 20 March 2018.
Electronic supplementary material
The online version of this article (10.1186/s13063-019-3335-2) contains supplementary material, which is available to authorized users.
Background
To determine whether maintaining ventilation during cardiopulmonary bypass (CPB) with a different fraction of inspired oxygen (FiO2) had an impact on the occurrence of postoperative pulmonary complications (PPCs).
Methods
A total of 413 adult patients undergoing elective cardiac surgery with CPB were randomly assigned into three groups: 138 in the NoV group (received no mechanical ventilation during CPB), 138 in the LOV group (received a tidal volume (VT) of 3–4 ml/kg of ideal body weight with the respiratory rate of 10–12 bpm, and the positive end-expiratory pressure of 5–8 cmH2O during CPB; the FiO2 was 30%), and 137 in the HOV group (received the same ventilation parameters settings as the LOV group while the FiO2 was 80%).
Results
The primary outcomes were the incidence and severity of PPCs during hospitalization. The composite incidence of PPCs did not significantly differ between the NoV (63%), LOV (49%) and HOV (57%) groups (P = 0.069). And there was also no difference regarding the incidence of PPCs between the non-ventilation (NoV) and ventilation (the combination of LOV and HOV) groups. The LOV group was observed a lower proportion of moderate and severe pulmonary complications (grade ≥ 3) than the NoV group (23.1% vs. 44.2%, P = 0.001).
Conclusion
Maintaining ventilation during CPB did not reduce the incidence of PPCs in patients undergoing cardiac surgery.
Trial registration: Chinese Clinical Trial Registry ChiCTR1800015261. Prospectively registered 19 March 2018. http://www.chictr.org.cn/showproj.aspx?proj=25982
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