Perioperative Change of Regional Ventilation During Spontaneous Breathing
研究概览
详细说明
Postoperative pulmonary complications (Defined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency subsequent to surgery) increase the morbidity and mortality of surgical patients. Several independent factors determined by the patients' characteristics and the operative procedure increase the risk for those complications. The postoperative decrease of values measured by spirometry, such as the forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), were found in patients after major surgical procedures for several days. The postoperative reduction of those measurement can be the result of general functional limitations in those patients (e.g. by postoperative pain) or the result of a regional postoperative pulmonary complication (e.g. atelectasis, pleural effusion). The method of the electrical impedance tomography (EIT) enables to visualize the regional ventilation within a transversal section of the lung in real time. Studies examining the change of pulmonary EIT for several days postoperatively in spontaneously breathing patients are lacking. The aim of the present study is to examine perioperative changes in regional ventilation in spontaneously breathing patients during their recovery after abdominal and limb surgery. Moreover, the association of those changes with expected changes in spirometry is tested. Finally, in patients with evident postoperative pulmonary complications the value of pulmonary EIT to detect those changes is investigated. The study should improve the knowledge about the development of postoperative pulmonary complications and test the scientific and clinical value of pulmonary EIT in those spontaneously breathing patients.
In a group of patients undergoing osteosynthesis of a flail chest, it is tested how regional ventilation changes by these operations and whether pulmonary EIT is actually usable in these patients.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Würzburg、德国、97080
- University of Würzburg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Adult
- Inpatient
- Surgery under general anesthesia with and without additional regional anesthesia
- increased risk for postoperative pulmonary complications according to the ARISCAT-Score (except pilot arm for osteosynthesis of flail chest)
Exclusion Criteria:
- Missing informed consent
- Outpatient
- Emergency procedure
- Revision surgery of hospitalized patients
- Operation under local or regional anesthesia alone
- Expected postoperative ventilation
- Expected hospital stay of less than three days
- Pregnancy
- Allergy against material of the electrode belt (silicone rubber, stainless steel, gold-plated brass)
- Injured, inflamed or otherwise affected skin within the target region of the electrode belt
- Unstable spine injury
- Body mass index of more than 50 kg/m2
- Incapacity to lie quietly for the examination
- Pacemaker, defibrillator or other active implant
- Reoperation before the examination at the third postoperative day
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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abdominal surgery
27 patients undergoing abdominal surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
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Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
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limb surgery
27 patients undergoing upper and lower limb surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests
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Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
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flail chest
10 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests
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Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in regional ventilation at the first postoperative day
大体时间：baseline and 1. postoperative day
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Regional ventilation is measured by pulmonary electrical impedance tomography.
The change in the calculated 'Center of Ventilation' in the sagittal direction is used for the primary outcome measure.
Power calculation accounts for the use of two time points for the primary outcome measure.
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baseline and 1. postoperative day
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Change from baseline in regional ventilation at the third postoperative day
大体时间：baseline and 3. postoperative day
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Regional ventilation is measured by pulmonary electrical impedance tomography.
The change in the calculated 'Center of Ventilation' in the sagittal direction is used for the primary outcome measure.
Power calculation accounts for the use of two time points for the primary outcome measure.
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baseline and 3. postoperative day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in forced vital capacity (FVC)
大体时间：baseline, 1. and 3. postoperative day
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Measured by spirometry.
The best value of three attempts is used.
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baseline, 1. and 3. postoperative day
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in forced expiratory volume in one second (FEV1)
大体时间：baseline, 1. and 3. postoperative day
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Measured by spirometry.
The best value of three attempts is used.
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baseline, 1. and 3. postoperative day
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Change in peripheral oxygen saturation
大体时间：baseline, 1. and 3. postoperative day
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Measured by pulse oximetry
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baseline, 1. and 3. postoperative day
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Change in pain score
大体时间：baseline, 1. and 3. postoperative day
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Measured by visual analogue scale
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baseline, 1. and 3. postoperative day
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Change in respiratory rate
大体时间：baseline, 1. and 3. postoperative day
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Measured by electric impedance tomography
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baseline, 1. and 3. postoperative day
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pulmonary complications
大体时间：baseline, 1., 3. and 7. postoperative day or at discharge
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Defined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency
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baseline, 1., 3. and 7. postoperative day or at discharge
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合作者和调查者
调查人员
- 首席研究员：Markus Kredel, PD. Dr. med、University of Würzburg, Department of Anaesthesia and Critical Care
出版物和有用的链接
一般刊物
- Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
- Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20.
- Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23.
- Karayiannakis AJ, Makri GG, Mantzioka A, Karousos D, Karatzas G. Postoperative pulmonary function after laparoscopic and open cholecystectomy. Br J Anaesth. 1996 Oct;77(4):448-52. doi: 10.1093/bja/77.4.448.
- Guizilini S, Bolzan DW, Faresin SM, Alves FA, Gomes WJ. Ministernotomy in myocardial revascularization preserves postoperative pulmonary function. Arq Bras Cardiol. 2010 Oct;95(5):587-93. doi: 10.1590/s0066-782x2010005000137. Epub 2010 Oct 15. English, Portuguese.
- Davoudi M, Farhanchi A, Moradi A, Bakhshaei MH, Safarpour G. The Effect of Low Tidal Volume Ventilation during Cardiopulmonary Bypass on Postoperative Pulmonary Function. J Tehran Heart Cent. 2010 Summer;5(3):128-31. Epub 2010 Aug 31.
- Radke OC, Schneider T, Heller AR, Koch T. Spontaneous breathing during general anesthesia prevents the ventral redistribution of ventilation as detected by electrical impedance tomography: a randomized trial. Anesthesiology. 2012 Jun;116(6):1227-34. doi: 10.1097/ALN.0b013e318256ee08.
- Frerichs I, Hahn G, Golisch W, Kurpitz M, Burchardi H, Hellige G. Monitoring perioperative changes in distribution of pulmonary ventilation by functional electrical impedance tomography. Acta Anaesthesiol Scand. 1998 Jul;42(6):721-6. doi: 10.1111/j.1399-6576.1998.tb05308.x.
- Bauer M, Opitz A, Filser J, Jansen H, Meffert RH, Germer CT, Roewer N, Muellenbach RM, Kredel M. Perioperative redistribution of regional ventilation and pulmonary function: a prospective observational study in two cohorts of patients at risk for postoperative pulmonary complications. BMC Anesthesiol. 2019 Jul 27;19(1):132. doi: 10.1186/s12871-019-0805-8.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
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首次发布 (估计)
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上次提交的符合 QC 标准的更新
最后验证
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