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NCT06902220 | NOT YET RECRUITING | Postoperative Pulmonary Atelectasis

Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery
Sponsor:

Southeast University, China

Information provided by (Responsible Party):

jin official, XU

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, randomized controlled trial, we seek to establish evidence that could lead to improved postoperative pulmonary care and outcomes for cardiac surgery patients.

Condition or disease

Postoperative Pulmonary Atelectasis

Intervention/treatment

continuous high-frequency oscillation therapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 470 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery: a Study Protocol for a Multicenter Randomized Controlled Trial
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2027-01-01
Estimated Study Completion Date : 2027-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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.
Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery

Location Details

NCT06902220

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