Status:
NOT_YET_RECRUITING
Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery
Lead Sponsor:
Southeast University, China
Conditions:
Postoperative Pulmonary Atelectasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Our study aims to evaluate the effectiveness of continuous high-frequency oscillation therapy in reducing PPCs in patients following elective cardiac surgery. Through a prospective, multicenter, rando...
Eligibility Criteria
Inclusion
- Adult patients (18 years or older) undergoing elective cardiac surgery will be included. Participants must provide informed consent upon ICU admission and have at least one risk factor for PPCs, including age ≥ 75 years, American Society of Anesthesiologists (ASA) score ≥ 2, history of chronic obstructive pulmonary disease (COPD) stage ≥ 2 or asthma (moderate to severe), current heavy smoking or heavy smoking history within the past 6 months, obstructive sleep apnea, frailty index \> 0.21 or body max index (BMI) ≥ 30 kg/m².
Exclusion
- Patients will be excluded if they have contraindications for oscillation treatment (e.g., untreated tension pneumothorax); have pneumothorax or air leak syndrome at entry; require more than 2 μg/kg/min of norepinephrine; have been diagnosed with pneumonia within 2 weeks prior to surgery; have refractory arrhythmia at entry; have a left ventricular ejection fraction \< 35%; have mean pulmonary artery pressure (mPAP) \> 35 mmHg; are postoperative from spinal surgery within the past 2 weeks; require a ventricular assist device; have renal failure requiring continuous renal replacement therapy (CRRT) at entry; are planned for re-operation within 48 hours or have undergone organ transplantation.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT06902220
Start Date
September 1 2025
End Date
January 31 2027
Last Update
March 30 2025
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