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

NCT05519657 | Unknown DMC

• 1 other identifier: TJ2021S127
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pulmonary Complications; Risk Factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Risk factors of PPCs

  Up to 7 days

Other Outcomes (2)

• Mortality rate within 28 days from the date of surgery

  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.

Study Arms (2)

postoperative pulmonary complications group

Postoperative pulmonary complications group no intervention

non-postoperative pulmonary complications group

Non-postoperative pulmonary complications group no intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 29, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 29, 2022

Record last verified: 2022-08