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The effect of pressure-directed individualised lung-protective ventilation on postoperative diaphragmatic function in bariatric patients: a randomised controlled trial

The effect of pressure-directed individualised lung-protective ventilation on postoperative diaphragmatic function in bariatric patients: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110804
Enrollment
Unknown
Registered
2025-10-21
Start date
2025-10-21
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Trial group:Intraoperative individualized positive end-expiratory pressure (PEEP) ventilation strategy guided by driving pressure
Control group:Conventional fixed positive end-expiratory pressure (PEEP) ventilation strategy

Sponsors

Taizhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years; 2. 45 kg/m^2>BMI>=28 kg/m^2; 3. American Society of Anesthesiologists (ASA) physical status classification of II–III;

Exclusion criteria

Exclusion criteria: 1. History of respiratory conditions including airway narrowing or obstruction, chronic bronchitis, bronchial asthma, COPD, or bronchiectasis; 2. Abnormal diaphragmatic function or concomitant neuromuscular disorders with relevant medication history; 3. Patients with thoracic or abdominal trauma, chronic pain, long-term opioid analgesic use, or history of psychotropic medication; 4. Patients requiring preoperative assisted ventilation; 5. Patients with severe cardiovascular disease history (e.g., significant arrhythmia, heart failure, angina pectoris, myocardial infarction); 6. Patients with allergy to any anaesthetic agent in the proposed regimen; 7. Patients who refuse or fail to sign the informed consent form;

Design outcomes

Primary

MeasureTime frame
Diaphragm thickness at end-inspiration;End-expiratory diaphragm thickness;Diaphragm thickening fraction;Diaphragmatic excursion during quiet breathing;Deep breathing diaphragmatic mobility;

Secondary

MeasureTime frame
Respiratory mechanics parameters (including end-tidal carbon dioxide, heart rate, mean arterial pressure, oxygen saturation, airway plateau pressure, airway peak pressure, etc.);Oxygen Index (OI);Mechanical ventilation, pneumoperitoneum duration;OAA/S and NRS scores at T1 and T2;Pulmonary complications (atelectasis, pulmonary infection, hypoxemia) on postoperative day 1 and day 3;Incidence of postoperative nausea and vomiting (PONV);

Countries

China

Contacts

Public ContactJiang Lin

Taizhou People's Hospital

jianglin@njmu.edu.cn+86 151 6106 1166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026