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The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial.

ABSTRACT: 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 cmH2O, 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.

SUBMITTER: Zhang L

PROVIDER: S-EPMC5797412 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial.

Zhang Liyong L Xiong Wei W Peng Yuming Y Zhang Wei W Han Ruquan R

Trials 20180202 1

<h4>Background</h4>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.<h4>Methods</h4>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 patien ...[more]

PMID: 29394907

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Project description:BackgroundPost-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery.MethodsThis single-centre, pilot randomized clinical trial was conducted at the University Hospital "Maggiore della Carità" (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6-8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality.ResultsA total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups.ConclusionsLPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements.Trial registrationregistered on the Australian New Zealand Clinical Trial Registry ( www.anzctr.org.au ), registration number ACTRN12615000707561.

Project description:BackgroundPneumoperitoneum and Trendelenburg position in laparoscopic surgeries could contribute to postoperative pulmonary dysfunction. In recent years, intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator-induced lung injuries (VILI). Our objectives were to test the hypothesis that LPV could improve intraoperative oxygenation function, pulmonary mechanics and early postoperative atelectasis in laparoscopic surgeries.MethodsIn this randomized controlled clinical trial, 62 patients indicated for elective abdominal laparoscopic surgeries with an expected duration of greater than 2 h were randomly assigned to receive either lung-protective ventilation (LPV) with a tidal volume (Vt) of 7 ml kg- 1 ideal body weight (IBW), 10 cmH2O positive end-expiratory pressure (PEEP) combined with regular recruitment maneuvers (RMs) or conventional ventilation (CV) with a Vt of 10 ml kg- 1 IBW, 0 cmH2O in PEEP and no RMs. The primary endpoints were the changes in the ratio of PaO2 to FiO2 (P/F). The secondary endpoints were the differences between the two groups in PaO2, alveolar-arterial oxygen gradient (A-aO2), intraoperative pulmonary mechanics and the incidence of atelectasis detected on chest x-ray on the first postoperative day.ResultsIn comparison to CV group, the intraoperative P/F and PaO2 in LPV group were significantly higher while the intraoperative A-aO2 was clearly lower. Cdyn and Cstat at all the intraoperative time points in LPV group were significantly higher compared to CV group (p < 0.05). There were no differences in the incidence of atelectasis on day one after surgery between the two groups.ConclusionsLung protective mechanical ventilation significantly improved intraoperative pulmonary oxygenation function and pulmonary compliance in patients experiencing various abdominal laparoscopic surgeries, but it could not ameliorate early postoperative atelectasis and oxygenation function on the first day after surgery.Trial registrationhttps://www.clinicaltrials.gov/identifier: NCT04546932 (09/05/2020).

Project description:IntroductionIn lung cancer surgery, large tidal volume and elevated inspiratory pressure are known risk factors of acute lung (ALI). Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients. In the current study, we assessed the impact of a protective lung ventilation (PLV) protocol in patients undergoing lung cancer resection.MethodsWe performed a secondary analysis of an observational cohort. Demographic, surgical, clinical and outcome data were prospectively collected over a 10-year period. The PLV protocol consisted of small tidal volume, limiting maximal pressure ventilation and adding end-expiratory positive pressure along with recruitment maneuvers. Multivariate analysis with logistic regression was performed and data were compared before and after implementation of the PLV protocol: from 1998 to 2003 (historical group, n = 533) and from 2003 to 2008 (protocol group, n = 558).ResultsBaseline patient characteristics were similar in the two cohorts, except for a higher cardiovascular risk profile in the intervention group. During one-lung ventilation, protocol-managed patients had lower tidal volume (5.3 +/- 1.1 vs. 7.1 +/- 1.2 ml/kg in historical controls, P = 0.013) and higher dynamic compliance (45 +/- 8 vs. 32 +/- 7 ml/cmH2O, P = 0.011). After implementing PLV, there was a decreased incidence of acute lung injury (from 3.7% to 0.9%, P < 0.01) and atelectasis (from 8.8 to 5.0, P = 0.018), fewer admissions to the intensive care unit (from 9.4% vs. 2.5%, P < 0.001) and shorter hospital stay (from 14.5 +/- 3.3 vs. 11.8 +/- 4.1, P < 0.01). When adjusted for baseline characteristics, implementation of the open-lung protocol was associated with a reduced risk of acute lung injury (adjusted odds ratio of 0.34 with 95% confidence interval of 0.23 to 0.75; P = 0.002).ConclusionsImplementing an intraoperative PLV protocol in patients undergoing lung cancer resection was associated with improved postoperative respiratory outcomes as evidence by significantly reduced incidences of acute lung injury and atelectasis along with reduced utilization of intensive care unit resources.

Project description:BackgroundThere is a major paradigm shift for intraoperative mechanical ventilator support by the introduction of lung protective ventilation strategies to reduce postoperative pulmonary complications and improve overall clinical outcomes in non-thoracic surgeries. However, there is currently a lack of standardized practice guideline for lung protection during thoracic surgeries that require one-lung ventilation (OLV). This study aimed to collect the expert opinions of the thoracic anesthesiologists in perioperative care for OLV surgery in Taiwan.MethodsThis prospective cross-sectional study was undertaken in 16 tertiary hospitals in Taiwan from January to February 2019. A structured survey form was distributed across the participating hospitals and the thoracic anesthesiologists were invited to complete the form voluntarily. The survey form consisted of three parts, including the basic information of the institutional anesthesia care standards, ventilatory settings for a proposed patient receiving OLV surgery and expert opinions on OLV.ResultsA total of 71 thoracic anesthesiologists responded to the survey. Double-lumen tubes are the most commonly used (93.8%) airway devices for OLV. The most commonly recommended ventilator setting during OLV is a tidal volume of 6-7 ml/kg PBW (67.6%) and a PEEP level of 4-6 cmH2O (73.5%). Dual controlled ventilator modes are used by 44.1% of the anesthesiologists. During OLV, high oxygen fraction (FiO2 > 0.8) is more commonly supplemented to achieve an oxygen saturation higher than 94%. The consensus of anesthesiologists on the indices for lung protection in thoracic surgery is considerably low. Large majority of the anesthesiologists (91.5%) highly recommend that an international clinical practice guideline on the protective lung ventilation strategy for thoracic anesthesia should be established.ConclusionsThis study found that the thoracic anesthesiologists in Taiwan share certain common practices in ventilator support during OLV. However, they are concerned about the lack of fundamental clinical evidences to support the beneficial outcomes of the current lung protective strategies applicable to OLV. Large-scale trials are needed to form an evidence-based clinical practice guideline for thoracic anesthesia.

Project description:IntroductionCerebral oxygenation can be monitored clinically by cerebral oximetry (regional oxygen saturation, rSO2) using near-infrared spectroscopy (NIRS). Changes in rSO2 have been shown to precede changes in pulse oximetry, providing an early detection of clinical deterioration. Cerebral oximetry values may be affected by various factors, including changes in ventilation. The aim of this study was to evaluate the changes in rSO2 during intraoperative changes in mechanical ventilation.Patients and methodsFollowing the approval of the institutional review board (IRB), tissue and cerebral oxygenation were monitored intraoperatively using NIRS. Prior to anesthetic induction, the NIRS monitor was placed on the forehead and over the deltoid muscle to obtain baseline values. NIRS measurements were recorded each minute over a 5-min period during general anesthesia at four phases of ventilation: 1) normocarbia (35-40 mmHg) with a low fraction of inspired oxygen (FiO2) of 0.3; 2) hypocarbia (25-30 mmHg) and low FiO2 of 0.3; 3) hypocarbia and a high FiO2 of 0.6; and 4) normocarbia and a high FiO2. NIRS measurements during each phase were compared with sequential phases using paired t-tests.ResultsThe study cohort included 30 adolescents. Baseline cerebral and tissue oxygenation were 81% ± 9% and 87% ± 5%, respectively. During phase 1, cerebral rSO2 was 83% ± 8%, which decreased to 79% ± 8% in phase 2 (hypocarbia and low FiO2). Cerebral oxygenation partially recovered during phase 3 (81% ± 9%) with the increase in FiO2 and then returned to baseline during phase 4 (83% ± 8%). Each sequential change (e.g., phase 1 to phase 2) in cerebral oxygenation was statistically significant (p < 0.01). Tissue oxygenation remained at 87%-88% throughout the study.ConclusionCerebral oxygenation declined slightly during general anesthesia with the transition from normocarbia to hypocarbic conditions. The rSO2 decrease related to hypocarbia was easily reversed with a return to baseline values by the administration of supplemental oxygen (60% vs. 30%).

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The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial.

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The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial.

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