Using driving pressure to guide ventilation in obese children during surgery
Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in Obese Children: a Prospective, Randomized Controlled Clinical Trial
This study is testing if adjusting breathing support based on lung pressure can help prevent lung problems in obese children during and after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Henan Provincial People's Hospital Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06471491 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of driving pressure-guided positive end-expiratory pressure (PEEP) in preventing postoperative atelectasis in obese children undergoing elective surgery. The study compares two groups: one receiving individualized PEEP adjustments based on driving pressure and another receiving a fixed PEEP. The aim is to determine if the tailored approach can reduce the incidence of lung complications post-surgery. Lung ultrasound will be utilized to assess the outcomes between the two ventilation strategies.
Who should consider this trial
Good fit: Ideal candidates are obese children aged 3-18 years who are undergoing elective surgery with general anesthesia.
Not a fit: Patients with severe pulmonary dysfunction or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative lung complications in obese children.
How similar studies have performed: While there is limited research specifically on obese children, similar lung protective ventilation strategies have shown promise in adult populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhengzhou, Henan
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Qian Wang
- Email: 1439007623@qq.com
- Phone: 19103852131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.