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

NCT06471491 | Completed

• 1 other identifier: PEEP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of atelectasis in both groups at the end of surgery

  Incidence of atelectasis in both groups at the end of surgery

  at the end of surgery

Study Arms (2)

Lung protective ventilation group

EXPERIMENTAL

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.

Other: Driving pressure-guided positive end-expiratory pressure

Traditional mechanical ventilation group

NO INTERVENTION

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

Interventions

Driving pressure-guided positive end-expiratory pressure OTHER

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

Lung protective ventilation group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 453100, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Zhou

  Henan Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 24, 2024
• Study Start: September 11, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 15, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)