Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06902220

Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

continuous high-frequency oscillation therapy

Device

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 outcomes

  1. 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

    The severity of PPCs within 7 postoperative days will be assessed using an ordinal scale from 0 to 5, based on a modified definition of PPCs. Grade 0 indicated no symptoms, grade 4 represented reintubation or invasive mechanical ventilation for 48 hours or more and grade 5 indicated death before hospital discharge. PPCs occurrence and severity will be evaluated daily until 7 postoperative days or hospital discharge, using the worst score during the hospital stay for the primary analysis. Bedside chest radiographs will be performed on the first postoperative day, followed by echocardiograms on the second and third days, in addition to those requested by attending physicians.

Secondary outcomes

  1. incidence of > 48 hours invasive mechanical ventilation

    Time frame: within 7 postoperative days

  2. duration of mechanical ventilation

    Time frame: within 7 postoperative days

Study contacts

Contact information is provided by the study sponsor or research team.

Jingyuan Xu, M.D.

CONTACT

[email protected]

8602583262550

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery: a Study Protocol for a Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.