Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in Obese Children: a Prospective, Randomized Controlled Clinical Trial

NCT ID: NCT06471491

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2025-03-15

Brief Summary

At present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. Although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. Therefore, the investigators hypothesized that intraoperative use of LPV strategies in obese pediatric surgery patients can reduce atelectasis and improve the incidence of postoperative pulmonary complications.

Detailed Description

In the lung protective ventilation group, PEEP was titrated individually in a sequential manner after mechanical ventilation. According to previous studies, PEEP was 5 cmH2O, inspiratory pressure was 20 cmH2O, and respiratory rate was set according to patient age. PEEP and inspiratory pressure were increased by 5 cmH2O every 30 seconds until PEEP was 15 cmH2O and inspiratory pressure 30 cmH2O. This was followed by a decreasing amplitude of 2 cmH2O to 3 cmH2O starting from 15 cmH2O, and each PEEP level was maintained for 4 to 5 respiratory cycles.The PEEP was at the lowest driving pressure was applied throughout the procedure. The PEEP level resulting in the lowest driving pressure was applied during surgery. In the traditional mechanical ventilation group, a fixed PEEP of 5 cm H2O was applied. The investigators compared the incidence of postoperative atelectasis between the two groups using lung ultrasound.

Conditions

Driving Pressure; Positive End-expiratory Pressure; Postoperative Atelectasis; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Lung protective ventilation group

PEEP was titrated individually in a sequential manner after mechanical ventilation. According to previous studies, PEEP was 5 cmH2O, inspiratory pressure was 20 cmH2O, and respiratory rate was set according to patient age. PEEP and inspiratory pressure were increased by 5 cmH2O every 30 seconds until PEEP was 15 cmH2O and inspiratory pressure 30 cmH2O. This was followed by a decreasing amplitude of 2 cmH2O to 3 cmH2O starting from 15 cmH2O, and each PEEP level was maintained for 4 to 5 respiratory cycles.The PEEP was at the lowest driving pressure was applied throughout the procedure. The PEEP level resulting in the lowest driving pressure was applied during surgery.

Group Type: EXPERIMENTAL

Driving pressure-guided positive end-expiratory pressure

Intervention Type: OTHER

Driving pressure-guided positive end-expiratory pressure during the surgical procedure

Traditional mechanical ventilation group

In the traditional mechanical ventilation group, a fixed PEEP of 5 cm H2O was applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Driving pressure-guided positive end-expiratory pressure

Driving pressure-guided positive end-expiratory pressure during the surgical procedure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 3-18 years old;
• According to the People's Republic of China health industry standard "Overweight and Obesity Screening threshold for school-age children and adolescents WS_T586-2018" defined as obesity;
• American Society of Anesthesiologists (ASA) grades I - II;
• Children with healthy lungs and hearts;
• Patients with general anesthesia under tracheal intubation;
• Clear mind and able to cooperate with the anesthesiologist to receive treatment;
• Patients who plan to have elective surgery under general anesthesia and the estimated operation duration is ≥2 hours.

Exclusion Criteria

• PEEP contraindications: (a) bronchopleural fistula; (b) hypovolemic shock; (c) right ventricular failure;
• American Society of Anesthesiologists (ASA) grade greater than II;
• Pulmonary dysfunction, congenital heart disease children;
• Refusal to participate in the study and/or use personal data, preoperative intubation or ventilation of children;
• Children with upper respiratory tract infection within 2 weeks.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Zhou

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Locations

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

PEEP

Identifier Type: -

Identifier Source: org_study_id