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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Risk Factors; Postoperative Pulmonary Complications
• Intervention / Treatment: Other

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.

• Study Type: Observational
• Enrollment (Anticipated): 154

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Preoperative: age, sex, height, weight, ASA grade, smoking history, preoperative comorbidities (hypertension, diabetes, coronary heart disease, chronic kidney disease, cerebrovascular disease, COPD), medication history, pulse oxygen saturation, white blood cell count, hemoglobin level, albumin level.

Intraoperative: operation time (cut skin to sew leather end), anesthesia time (anesthesia induction to tracheal extubation), mechanical ventilation parameters, completion of vital signs, muscle relaxant antagonism, whether the implementation of regional block, infusion, blood loss, amount of urine, perioperative medications (opioids dosage adjustments based on weight and anesthesia time).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
postoperative pulmonary complications group; Postoperative pulmonary complications group no intervention
non-postoperative pulmonary complications group; Non-postoperative pulmonary complications group no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors of PPCs	Risk factors of PPCs in elderly patients undergoing robot assisted laparoscopic pelvic surgery	Up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TJ2021S127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No