Effects of lung protective ventilation on pulmonary function, inflammation, and oxidative stress in patients undergoing craniotomy: study protocol for a multi-center, randomized, parallel, controlled trial

Abstract

Background: Conventional mechanical ventilation often leads to lung inflammatory responses and oxidative stress, influencing a patient's prognosis. Lung protective ventilation has been widely used during one-lung ventilation and abdominal surgeries as it can reduce lung tissue injury and improve systemic oxygenation. However, there are few reports on its use during craniotomy. Methods/Design: This multi-center, randomized, parallel, controlled trial will be performed at Anhui Provincial Hospital (Southern District), and the Renmin Hospital of Wuhan University, China. Sixty patients scheduled to undergo craniotomy and meeting our eligibility criteria will be randomly allocated to undergo either lung protective ventilation (6 mL/kg tidal volume, 10 cmH 2 O positive end-expiratory pressure, respiratory frequency 15 breaths/min; n = 30) or conventional mechanical ventilation (10 mL/kg tidal volume, respiratory frequency 12 breaths/min; n = 30). All patients will be evaluated from just prior to surgery (at changing of the ventilation mode) to immediately after extubation. The primary outcome measure will be dynamic lung compliance. The secondary outcome measures will be respiratory index, mean airway pressure, plateau pressure, alveolar and plasma markers of inflammation, and oxidative stress. Discussion: The outcomes will reveal the effects of a protective ventilation strategy using low tidal volumes and the use of positive end-expiratory pressure on respiratory status, postoperative pulmonary and systemic inflammation, and oxidative stress in patients undergoing craniotomy. This will provide objective evidence for the safety of protective ventilation during craniotomy. Trial registration: This trial was registered at Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-16008029) on 1 March 2016. Ethics: The study protocol was approved by the Ethics Committee of Anhui Provincial Hospital, China (approval number: 2014-59) on 27 November 2014 and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians.