Respiratory Failure in Esophagectomy. Results After Implantation of Enhanced Recovery After Surgery Protocol.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-operative respiratory failure
研究概览
简要总结
Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in esophagectomy reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.
With the aim of improving morbimortality in patients undergoing esophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.
详细描述
Esophageal carcinoma is the sixth leading cause of cancer death worldwide and the main treatment still remains oesophagectomy, a technique associated with a high morbidity and mortality rate. Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in these patients reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.
With the aim of improving morbimortality in patients undergoing oesophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.
The secondary objectives are to analyse the changes produced in terms of morbimortality after the implementation of the protocol and the repercussion of these changes on the length of stay in the Resuscitation Unit.
To carry out this project, data obtained in the first instance from patients operated before the implementation of the enhanced recovery after surgery protocol will be compared with data obtained prospectively after the implementation of the protocol.
The data will be collected from the computerised and digitalised medical records of the patients on Orion Clinic® and Interspace intelligence Critical Care and Anesthesia, Philips ®. Patients operated on between 19 October 2020 and 19 October 2021 will be included consecutively. Prior to the operation, patients must sign an informed consent form to authorize the monitoring of their data during the first 30 days after the operation. These data will include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergone esophagectomy due to neoplastic causes
- •Ages between 18 and 90
- •Programmed surgery
排除标准
- •Caustic esophagitis
- •Esophagectomy for stomach cancer
- •Congenital oesophageal malformations
- •Respiratory failure at the time of surgery
- •Re-interventions of esophagectomy
- •Unexpected intraoperative surgical problems
结局指标
主要结局
Post-operative respiratory failure
时间窗: 1 month
Post-operative respiratory failure in esophagectomy after introduction of Enhanced Recovery After Surgery protocol
次要结局
- Other morbidity(1 month)
- Main predisposing factors(1 month)
- Stay at ICU(1 month)
- Respiratory failure as a prognostic factor(1 month)
研究者
Raquel Ferrandis Comes
Doctor
Instituto de Investigacion Sanitaria La Fe