跳至主要内容
临床试验/CTRI/2018/07/014946
CTRI/2018/07/014946尚未招募不适用

Post- operative pulmonary complications-Incidence and Risk factors in patients undergoing major abdominal cancer surgery

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2018年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
350
试验地点
1
主要终点
Incidence of post-operative pulmonary complications in patients undergoing major abdominal cancer surgery

研究概览

简要总结

Despite the advancement in the peri-operative care, surgical complications do occur and curtail the recovery of the patient. Amongst them pulmonary complications are the most frequent in upper abdominal surgeries in the post-operative period.

Post-operative pulmonary complications (PPC)encompass a wide range of conditions ranging from atelectasis requiring administering of oxygen to ARDS requiring invasive mechanical ventilation. These pulmonary complications increase the risk of morbidity and mortality, length of hospital stay and hence the health -related cost. There are numerous risk factors, which predispose the patient to these complications. Greater the number of risk factors higher the risk of developing complications. The risk factors are categorised as patient, surgical and anaesthesia related factors. Some of these factors are modifiable and some are not. Patient factors are age, male gender, high BMI, history of smoking and alcohol consumption, higher ASA grade, preoperative impaired mobility, respiratory infection within a month before surgery.  Surgery related factors are type of incision, its site, prolonged surgery (>210 minutes), contaminated surgical procedure. Anaesthesia related are prolonged duration, intraoperative positive fluid balance, failure to use protective lung ventilation strategy, presence of nasogastric tube at the end of the surgery, elective mechanical ventilation post-operatively and inadequate post-op analgesia.

Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) study addressed the problem of differences across surgical contexts by using a population based approach that was representative of a wide range of procedures and patients in a geographically defined, mixed urban-rural practice setting (in Spain). It is clinically practical seven-factor scoring system used to assess the risk of a composite PPC. We have implemented Enhanced recovery program a few years back which takes into consideration some of the above mentioned factors and optimises patient before surgery.  Therefore, we would like to study the incidence of postoperative pulmonary complications and associated risk factors in patients undergoing major abdominal cancer surgery and evaluate the accuracy of ARISCAT score in predicting postoperative pulmonary complications.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Patients aged 18 years or more Patients undergoing elective hepatic, pancreatic and HIPEC surgery.

排除标准

  • •Pregnant and lactating women Patient refusal to participate in this study.

结局指标

主要结局

Incidence of post-operative pulmonary complications in patients undergoing major abdominal cancer surgery

时间窗: Before the discharge from hospital

次要结局

  • Risk factors associated with post-operative pulmonary complications and outcomes such as length of stay (ICU and postoperative), discharge status (alive or dead), need for readmission within 30 days of discharge. Predictive ability of ARISCAT in our patients undergoing major abdominal surgery(Within 30 days of hospital discharge)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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