Pulmonary Complications in Elderly Patients

NCT06517550 | Completed

• 1 other identifier: 2021-HX-54
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of pulmonary complications

  30 and 90 days after surgery

Study Arms (2)

PEEP 5 cmH2O

NO INTERVENTION

During the surgical mechanical ventilation process, a constant PEEP value of 5 cmH2O is set.

Personalized PEEP

EXPERIMENTAL

During surgical mechanical ventilation, individualized PEEP values are set based on each patient's lung condition.

Other: positive end-expiratory pressure while mechanical ventilation

Interventions

positive end-expiratory pressure while mechanical ventilation OTHER

a parameter in ventilator

Personalized PEEP

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng X Ren, doctor

  China-Janpan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 14, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: two years after the research and they will be available forever
• Access Criteria: all researchers

Locations

CN (1)