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Clinical Trials/NCT05519657
NCT05519657
Unknown
Not Applicable

Incidence and Risk Factors of Postoperative Pulmonary Complications in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery: a Single Center, Prospective, Observational Study

Tongji Hospital0 sites154 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pulmonary Complications
Sponsor
Tongji Hospital
Enrollment
154
Primary Endpoint
Incidence of PPCs
Last Updated
3 years ago

Overview

Brief Summary

Postoperative pulmonary complications are important factors affecting the prognosis of patients undergoing surgery. Studies have shown that patients undergoing abdominal or pelvic surgery, emergency surgery, or prolonged surgery are more likely to develop PPCs, especially when robot-assisted laparoscopic surgery is performed at extreme head low. The incidence of PPCs and associated risk factors in patients undergoing robot-assisted laparoscopic surgery compared with those undergoing conventional surgery should be re-examined.

Detailed Description

PPCs include bronchospasm, atelectasis, lung infections (bronchitis and pneumonia), exacerbation of pre-existing chronic lung disease, the need for mechanical ventilation after surgery, and respiratory failure. Risk factors for PPCs include preoperative and intraoperative factors. Preoperative was mainly related to the primary status of patients, including age, weight, ASA grade, organ function status, medication history, hypoproteinemia, and concomitant chronic kidney disease, congestive heart failure, COPD, asthma, pulmonary interstitial disease, pulmonary hypertension, and OSA. In this study, elderly patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia were selected to prospectively collect basic characteristics, preoperative examination results and perioperative data, and determine the incidence and risk factors of PPCs in this high-risk population cohort. The aim of our study was to determine the incidence of PPCs in elderly patients undergoing robot-assisted laparoscopic pelvic surgery and to screen for associated risk factors.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
November 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Feng Gao

Professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥65 years old
  • Selective patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia

Exclusion Criteria

  • Patients undergoing oxygen therapy or mechanical ventilation before surgery
  • Patients who have received other surgical operations within 30 days
  • Patients who have previously undergone lung surgery

Outcomes

Primary Outcomes

Incidence of PPCs

Time Frame: Up to 7 days

One or more of the following conditions occurred: clinically diagnosed PPCs (pneumonia, bronchospasm, ARDS), radiographically diagnosed PPCs (atelectasis, pneumothorax, pleural effusion), postoperative respiratory insufficiency (requiring oxygen or non-invasive mechanical ventilation for more than 1 day), and postoperative tracheal intubation again;Respiratory infections: new or altered sputum properties, new or altered lung shadows, fever, white blood cell \>12 × 109/L;Respiratory failure: partial pressure of oxygen in the arterial blood while inhaling air\< 60 mmHg, pulse oxygen saturation\< 90%, or PaO2/FiO2 \< 300;Atelectasis, pneumothorax, pleural effusion: Chest X - ray diagnosis;Bronchospasm: wheezing sound can be relieved with bronchodilators.

Secondary Outcomes

  • Risk factors of PPCs(Up to 7 days)

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