Clinical trial NCT05519657: Incidence and Risk Factors of PPCs in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pulmonary Complications
Risk Factors
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 154
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Incidence of PPCs
timeFrame: Up to 7 days
Secondary outcomes:
measure: Risk factors of PPCs
timeFrame: Up to 7 days
Other outcomes:
measure: Mortality rate within 28 days from the date of surgery
timeFrame: Within 28 days from the date of surgery.
measure: Mortality rate within 90 days from the date of surgery
timeFrame: Within 90 days from the date of surgery.
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