跳至主要内容
临床试验/NCT06041750
NCT06041750尚未招募不适用

Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study

Cukurova University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年10月15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
500
试验地点
1
主要终点
postoperative pulmonary complications

研究概览

简要总结

It is known that perioperative respiratory complications occur more often in obstructive sleep apnea syndrome (OSAS) patients during general anesthesia. Although there are prospective RCTs in this area, the need for further and larger studies remains due to the heterogenity of the results. Moreover, the incidence of postoperative pulmonary complications in OSAS patients undergoing surgery in Turkey and the predictive factors affecting the respiratory adverse events are uncertain. Therefore, in this prospective observational cohort study, it was aimed to determine the incidence of postoperative pulmonary complications and the predictor factors associated with patient, anesthesia and surgery in surgical patients with a confirmed or highly suspected OSAS diagnosis undergoing general anesthesia.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-65 years
  • ASA physical status I-III
  • Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score)
  • Surgeries performed under general anesthesia
  • Endotracheal intubation facilitated by neuromuscular blockers

排除标准

  • ASA physical status IV or V
  • Planned admission to the ICU after surgery
  • Cardiac Surgery
  • Non-operating room anesthesia
  • Neuromuscular disease
  • Emergency or re-operational procedure
  • Laryngectomy
  • Pneumonectomy
  • Invasive airway access
  • Outpatient surgery

结局指标

主要结局

postoperative pulmonary complications

时间窗: Postoperative day 1, 2, 7 and 30.

The rate of postoperative hypoxia (respiratory failure), atelectasis, pulmonary edema /embolus, aspiration, bronchospasm, respiratory infection / pneumonia, pleural effusion, pneumothorax, respiratory arrest will be measured

次要结局

  • Mortality(Postoperative day 30.)
  • Non-invasive/invasive mechanical ventilation requirement(Postoperative day 1, 2, 7 and 30.)
  • Intensive care unit admission(Postoperative day 1, 2, 7 and 30.)
  • Predictive factors(Postoperative day 1, 2, 7 and 30.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Demet Laflı Tunay

Assistant Professor

Cukurova University

研究点 (1)

Loading locations...

相似试验