Incidence and Risk Factors of PPCs in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery

Risk Factors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05519657
• Other study ID #: TJ2021S127
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: August 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Pulmonary Complications
• Risk Factors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality rate within 28 days from the date of surgery	Within 28 days from the date of surgery, record the number of patients who died due to any cause and total number of observed cases. These two groups of clinical data will be combined to report "mortality rate" in "number of death cases/total number of observed cases".	Within 28 days from the date of surgery.
Other	Mortality rate within 90 days from the date of surgery	Within 90 days from the date of surgery, record the number of patients who died due to any cause and total number of observed cases. These two groups of clinical data will be combined to report "mortality rate" in "number of death cases/total number of observed cases".	Within 90 days from the date of surgery.
Primary	Incidence of PPCs	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.	Up to 7 days
Secondary	Risk factors of PPCs	Risk factors of PPCs in elderly patients undergoing robot assisted laparoscopic pelvic surgery	Up to 7 days