Abstract
ObjectiveThe objective of this trial is to investigate the effects of protective lung ventilation on regional cerebral oxygen saturation (rSO2) during dura opening, that is from Ta (after dura opening) to Tb (before dura closing), in patients undergoing intracranial tumor surgery.MethodsThis is a randomized controlled trial which will be carried out at the Second Affiliated Hospital of Soochow University. Fifty-four patients undergoing intracranial tumor surgery will be randomly allocated to the control group (C group) or the protective lung ventilation group (P group). In the C group, the tidal volume (VT) will be set at 8 ml/kg of predicted body weight, but positive end-expiratory pressure (PEEP) and recruitment maneuvers will not be used. In the P group, VT will be set at 6 ml/kg of predicted body weight combined with individualized PEEP during dura opening, while in other periods of general anesthesia, VT will be set at 8 ml/kg of predicted body weight. The level of rSO2, partial pressures of oxygen and carbon dioxide, oxygenation index, lactic acid level in arterial blood, and mean arterial pressure will be compared before anesthesia (T0), before dura opening (T1), after dura closing (T2), and 24 h after surgery (T3). Lung ultrasound scores will be measured at T0 and T3. The degree of brain relaxation at T1 and T2 will be evaluated by the surgeon using the brain relaxation scale. The amount of vasoactive drugs used and blood loss will be recorded during surgery. The duration of operation and reoperation rate will be recorded. The primary outcome of this study is the changes in rSO2 within 24 h postoperatively.DiscussionThis study aims to determine whether protective lung ventilation during dura opening can improve rSO2 and the state of pulmonary ventilation in patients undergoing intracranial tumor surgery, and to investigate whether this strategy affects the degree of brain tissue swelling and the reoperation rate after operation. If our results are positive, this study will show that protective lung ventilation during dura opening can be used effectively and safely in neurosurgical patients undergoing craniotomy for tumor resection.Trial registrationChinese Clinical Trial Registry, ChiCTR1900025632. Registered on 3 September 2019. chictr.org.cn.
Highlights
With the development of society and the progress of science and technology, more and more people receive delicate and complex procedures such as neurosurgery
The purpose of this study is to evaluate the effects of Protective lung ventilation (PLV) strategies with individualized positive end-expiratory pressure (PEEP) during dura opening on Regional cerebral oxygen saturation (rSO2) in patients undergoing intracranial tumor surgery
In the protective lung ventilation group (P group), Tidal volume (VT) will be set at 6 ml/kg of predicted body weight combined with individualized PEEP during intraoperative dura mater opening [6, 7], but in other periods of general anesthesia, VT will be set at 8 ml/kg of predicted body weight
Summary
Study design This is a single-center, randomized controlled trial which is being conducted at the Second Affiliated Hospital of Soochow University. All patients eligible for inclusion will be recruited continuously until recruitment completion. Patients will be randomized after signed informed consent and confirmation of inclusion and exclusion criteria. Patients who meet the enrollment criteria will be randomly allocated to the control group (C group) or the PLV group (P group). P group responsible for the anesthesia implementation will know the grouping but will not participate in the follow-up visit. The study intervention will be completed immediately after the surgery, but follow-up visits will extend to 1 week after surgery. Inclusion criteria Patients will be included if they fulfill all of the following criteria: 1. Exclusion criteria Patients will be excluded if they have any of the following criteria: 1. Termination criteria The following will cause participants to be terminated from the study: 1. Patients with significantly increased intraoperative ICP or swelling of brain tissue
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