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Clinical Trial Summary

This study was divided into two parts, taking elderly patients undergoing general anesthesia surgery as the research subjects, through factorial design: 1. It was verified that in elderly patients undergoing general anesthesia surgery, innovative lung-protective ventilation strategies can reduce the occurrence of atelectasis and reduce the incidence of ventilator-related lung injury and postoperative pulmonary complications more than traditional lung-protective ventilation strategies; 2. On the basis of part one study proving that innovative lung-protective ventilation strategies can reduce the incidence of postoperative atelectasis and other complications in elderly patients undergoing general anesthesia surgery compared with traditional lung-protective ventilation strategies, further comparisons were made between the two factors of "positive pressure extubation" and "improved early postoperative respiratory training" in the innovative lung protective ventilation strategy, and whether there was an interaction between the two.


Clinical Trial Description

More and more people need to undergo general anesthesia surgery at least once in the lifetime, and patients who undergo general anesthesia surgery often have postoperative pulmonary complications, and the occurrence of postoperative pulmonary complications is related to the prolongation of the patient's hospital stay and postoperative mortality. This is contrary to the current goal of rapid postoperative recovery. The International Expert Consensus on Strategies for Pulmonary Protective Ventilation states that age > 50 years is one of the greatest risk factors for postoperative pulmonary complications. This means that even older patients with largely unimpaired preoperative lung function are more likely to develop postoperative pulmonary complications than younger patients. Therefore, the investigators set the study to elderly patients undergoing general anesthesia surgery. The traditional lung-protective ventilation strategies commonly used to reduce atelectasis and ventilator-related lung injury during general anesthesia surgery is controversial and mixed. Based on literature review and preliminary experiments, this study focuses on extubation and post-extubation, which is a critical period of atelectasis development, combines positive pressure extubation technology with improved postoperative early breathing training, replaces the controversial continuous positive airway pressure(CPAP)support and alveolar recruitment manoeuvres in traditional lung protective ventilation strategies, and explores a new respiratory management strategy with more operability and clinical effect to reduce complications such as postoperative atelectasis in elderly patients. This study was originally a single-center clinical study and has been registered in the Chinese Clinical Trial Registry(Registration number:ChiCTR2300071364). It was later changed to a multi-center clinical study, so it was re-registered. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06021249
Study type Interventional
Source Fujian Medical University Union Hospital
Contact Lingli Pan
Phone +86 18065184976
Email panlin199104@163.com
Status Recruiting
Phase N/A
Start date September 28, 2021
Completion date June 2024

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