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Effects of Transesophageal Ultrasound-Guided Individualized Lung Recruitment Strategies on Perioperative Lung Protection and Cognitive Function in Cardiac Surgery Patients: A Multicenter, Prospective, Parallel-Group, Randomized Controlled Study

Effects of Transesophageal Ultrasound-Guided Individualized Lung Recruitment Strategies on Perioperative Lung Protection and Cognitive Function in Cardiac Surgery Patients: A Multicenter, Prospective, Parallel-Group, Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124020
Enrollment
Unknown
Registered
2026-05-06
Start date
2026-05-10
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Postoperative Pulmonary Complications Following Cardiac Surgery

Interventions

Individualized Lung Recruitment Group:TEE-Guided Individualized Lung Recruitment Group: Identical to the control group in terms of tidal volume (6-8 mL/kg) and baseline PEEP (5 cmH?O). The core interv
Standard Lung-Protective Ventilation Group:This group received fixed ventilation parameters throughout the procedure. Tidal volume was set at 6-8 mL/kg (ideal body weight), and positive end-expiratory

Sponsors

The First Affiliated Hospital of Bengbu Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Signed and dated informed consent form: The patient or their legal representative must voluntarily sign a written informed consent form with the current date before the surgery, after being fully informed. 2. Commitment to comply with the study procedures and cooperate with the entire research process: The patient must commit to and be able to cooperate in completing all perioperative interventions specified in the study protocol, daily evaluations during hospitalization, postoperative blood sample collection, and telephone follow-ups at 1 month and 3 months after surgery. 3. Specified gender or age range: Age 45 to 80 years (inclusive), any gender. 4. Meeting specific disease diagnosis, signs and symptoms, or generally good health: Planned to undergo elective cardiac surgery under cardiopulmonary bypass, including coronary artery bypass graft (CABG) or cardiac valve replacement/repair. American Society of Anesthesiologists (ASA) physical status classification II or III. Cardiac function is adequate, with preoperative left ventricular ejection fraction (LVEF) = 50%. 5. Meeting specific laboratory test results: No severe hepatic or renal dysfunction, with specific criteria as follows: estimated glomerular filtration rate (eGFR) = 30 ml/min/1.73 m^2, and not on long-term renal replacement therapy. Liver function Child-Pugh classification A. 6. Able to adhere to and cooperate with study interventions: The patient must be able to tolerate and cooperate with intraoperative transesophageal echocardiography (TEE) and adjustments of mechanical ventilation strategies according to group assignment. The study intervention involves a single intraoperative procedure and short-term postoperative ventilation parameter maintenance, without the need for long-term oral medication.

Exclusion criteria

Exclusion criteria: 1. Emergency, rescue, or secondary thoracotomy surgery. 2. Preoperative comorbid severe chronic obstructive pulmonary disease (COPD, GOLD grade >= 2) or severe pulmonary hypertension (pulmonary artery systolic pressure > 60 mmHg). 3. Preoperative history of definite central nervous system disease (such as post-stroke sequelae, dementia, Parkinson's disease, Clinical Dementia Rating scale >= 1). 4. Severe liver dysfunction (Child-Pugh class B or C) or severe renal insufficiency (preoperative eGFR < 30 ml/min/1.73 m^2 or long-term renal replacement therapy). 5. Presence of contraindications to esophageal ultrasound examination (such as esophageal stenosis, tumor, varices, recent bleeding, etc.). 6. Preoperative cognitive impairment (Montreal Cognitive Assessment basic score < 24, adjusted for years of education). 7. Severe malnutrition (BMI < 18.5 kg/m^2). 8. Currently participating in other interventional clinical trials that may interfere with the results of this study.

Design outcomes

Primary

MeasureTime frame
Incidence of Moderate-to-Severe Postoperative Pulmonary Complications (PPCs);Postoperative delirium (POD);

Secondary

MeasureTime frame
Oxygenation Function;Recovery Efficiency Metrics / Indices;Neurocognitive Function;Inflammation markers;Neuronal damage markers;

Countries

China

Contacts

Public ContactLiu Di

The First Affiliated Hospital of Bengbu Medical University

53241@bbmc.edu.cn+86 151 7834 0995

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026