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CLINICAL TRIAL PROTOCOL
JOURNAL ARTICLE
The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial.
Trials 2018 Februrary 3
BACKGROUND: Ventilator-induced lung injury is a major cause of postoperative pulmonary complications (PPCs) in patients undergoing neurosurgery after general anesthesia. However, there is no study on the effect of a lung-protective ventilation strategy in patients undergoing neurosurgery.
METHODS: This is a single-center, randomized, parallel-group controlled trial which will be carried out at Beijing Tiantan Hospital, Capital Medical University. Three hundred and thirty-four patients undergoing intracranial tumor surgery will be randomly allocated to the control group and the protective-ventilation strategy group. In the control group, tidal volume (VT) will be set at 10-12 ml/kg of predicted body weight but PEEP and recruitment maneuvers will not be used. In the protective group, VT will be set at 6-8 ml/kg of predicted body weight, PEEP at 6-8 cmH2 O, and a recruitment maneuver will be used intermittently. The primary outcome is pulmonary complications within 7 days postoperatively. Secondary outcomes include intraoperative brain relaxation, the postoperative complications within 30 days and the cost analysis.
DISCUSSION: This study aims to determine if the protective, pulmonary-ventilation strategy decreases the incidence of PPCs in patients undergoing neurosurgical anesthesia. If our results are positive, the study will indicate whether the protective, pulmonary-ventilation strategy is efficiently and safely used in neurosurgical patients undergoing the craniotomy.
TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02386683 . Registered on 18 October 2014.
METHODS: This is a single-center, randomized, parallel-group controlled trial which will be carried out at Beijing Tiantan Hospital, Capital Medical University. Three hundred and thirty-four patients undergoing intracranial tumor surgery will be randomly allocated to the control group and the protective-ventilation strategy group. In the control group, tidal volume (VT) will be set at 10-12 ml/kg of predicted body weight but PEEP and recruitment maneuvers will not be used. In the protective group, VT will be set at 6-8 ml/kg of predicted body weight, PEEP at 6-8 cmH2 O, and a recruitment maneuver will be used intermittently. The primary outcome is pulmonary complications within 7 days postoperatively. Secondary outcomes include intraoperative brain relaxation, the postoperative complications within 30 days and the cost analysis.
DISCUSSION: This study aims to determine if the protective, pulmonary-ventilation strategy decreases the incidence of PPCs in patients undergoing neurosurgical anesthesia. If our results are positive, the study will indicate whether the protective, pulmonary-ventilation strategy is efficiently and safely used in neurosurgical patients undergoing the craniotomy.
TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02386683 . Registered on 18 October 2014.
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