Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou, 215004, Jiangsu, China.
Department of Neurosurgery, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou, 215004, Jiangsu, China.
Trials. 2020 Feb 7;21(1):149. doi: 10.1186/s13063-019-4025-9.
The objective of this trial is to investigate the effects of protective lung ventilation on regional cerebral oxygen saturation (rSO) during dura opening, that is from Ta (after dura opening) to Tb (before dura closing), in patients undergoing intracranial tumor surgery.
This 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 rSO, 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 rSO within 24 h postoperatively.
This study aims to determine whether protective lung ventilation during dura opening can improve rSO 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.
Chinese Clinical Trial Registry, ChiCTR1900025632. Registered on 3 September 2019. chictr.org.cn.
本试验旨在研究开颅过程中保护性肺通气对颅内肿瘤手术患者脑区域氧饱和度（rSO）的影响，即从硬脑膜开放后的 Ta 到硬脑膜关闭前的 Tb。
这是一项在苏州大学附属第二医院进行的随机对照试验。将 54 例行颅内肿瘤手术的患者随机分为对照组（C 组）或保护性肺通气组（P 组）。在 C 组中，潮气量（VT）设定为预测体重的 8ml/kg，但不使用呼气末正压（PEEP）和复张手法。在 P 组中，在开颅过程中，VT 设置为预测体重的 6ml/kg，并结合个体化 PEEP，而在全身麻醉的其他时期，VT 设置为预测体重的 8ml/kg。在麻醉前（T0）、硬脑膜开放前（T1）、硬脑膜关闭后（T2）和手术后 24 小时（T3），比较 rSO、氧分压和二氧化碳分压、氧合指数、动脉血乳酸水平和平均动脉压。在 T0 和 T3 时测量肺超声评分。在 T1 和 T2 时，由外科医生使用脑松弛量表评估脑松弛程度。记录手术期间血管活性药物的使用量和出血量。记录手术时间和再次手术率。本研究的主要结局是术后 24 小时内 rSO 的变化。
本研究旨在确定开颅过程中保护性肺通气是否可以改善颅内肿瘤手术患者的 rSO 和肺通气状态，并探讨该策略是否会影响脑组织肿胀程度和术后再次手术率。如果我们的结果是积极的，本研究将表明，开颅过程中的保护性肺通气可以在接受开颅手术切除肿瘤的神经外科患者中安全有效地使用。
中国临床试验注册中心，ChiCTR1900025632。注册于 2019 年 9 月 3 日。chictr.org.cn。
