Pulmonary Complications in Elderly Patients

Effect of Protective Lung Ventilation Measures on Pulmonary Complications in Elderly Patients After Upper Abdominal Laparoscopy

The incidence of postoperative pulmonary complications in elderly patients undergoing upper abdominal laparoscopic surgery remains high, and the lung protective mechanical ventilation strategy aims to reduce the incidence of lung injury caused by ventilators. PEEP, as an important protective ventilation strategy, maintains end expiratory alveolar volume to improve intraoperative oxygenation and pulmonary respiratory mechanics, and plays a protective role in the lungs; Personalized PEEP is the most beneficial, especially for elderly patients. However, there is currently no ideal way to achieve precise and personalized regulation of PEEP. This project aims to target and control intraoperative mechanical ventilation to drive pressure, personalize PEEP titration, and conduct a randomized controlled study on perioperative changes in pulmonary oxygenation function and pulmonary complications in elderly patients undergoing upper abdominal laparoscopy.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: positive end-expiratory pressure while mechanical ventilation

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA<III、 general anesthesia, 60-80 years, BMI<30kg/m2, pneumoperitoneum time>0.5h, laparoscopic surgery on the upper abdomen (stomach, liver, gallbladder)

Exclusion Criteria:

• Severe anemia (Hb<60g/L), OSA, severe COPD (FEV1<30% pre), asthma, bronchiectasis, preoperative pulmonary infection, respiratory failure, thoracic deformity, postoperative return to ICU, heart function grade III-IV, severe liver and kidney dysfunction (Child B or C, dialysis), intraoperative bleeding greater than 30% of blood volume.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: PEEP 5 cmH2O; During the surgical mechanical ventilation process, a constant PEEP value of 5 cmH2O is set.
Experimental: Personalized PEEP; During surgical mechanical ventilation, individualized PEEP values are set based on each patient's lung condition.	Other: positive end-expiratory pressure while mechanical ventilation; a parameter in ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of oxygenation index	The patients' changes of Oxygenation index when leave-PACU, one-day after surgery and 7-day after surgery compared with pre-sugery oxygenation index	pre-surgery, leave-PACU, one-day after surgery and 7-day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pulmonary complications	Incidence of pulmonary complications at 30 and 90 days after surgery	30 and 90 days after surgery

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Feng X Ren, doctor, China-Janpan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: 2021-HX-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: two years after the research and they will be available forever
• IPD Sharing Access Criteria: all researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No