Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: continuous high-frequency oscillation therapy.
- Who it may be relevant to
- Registry conditions: Postoperative Pulmonary Atelectasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery: a Study Protocol for a Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- Device continuous high-frequency oscillation therapy
Once patients' CPOT score reaches 0, intubated patients will receive continuous high-frequency oscillation (CHFO) therapy three times daily, with 8-hour intervals and 10-minute sessions. Extubated patients will receive CHFO and continuous positive expiratory pressure (CPEP) therapy twice daily, with 12-hour intervals and 10-minute sessions.
Primary outcome measures
- The primary outcome is the pulmonary complication severity score within 7 postoperative days, or hospital discharge, whichever came sooner. [Time frame: within 7 postoperative days]
Secondary outcome measures (2)
- incidence of > 48 hours invasive mechanical ventilation [Time frame: within 7 postoperative days]
- duration of mechanical ventilation [Time frame: within 7 postoperative days]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06902220 · 2024ZDSYLL381-Y01