Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery

NCT06902220 | Not Yet Recruiting

• 1 other identifier: 2024ZDSYLL381-Y01
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pulmonary Atelectasis

Keywords

postcardiac surgery; oscillation; postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the pulmonary complication severity score within 7 postoperative days, or hospital discharge, whichever came sooner.

  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.

  within 7 postoperative days

Secondary Outcomes (2)

• incidence of > 48 hours invasive mechanical ventilation

  within 7 postoperative days

• duration of mechanical ventilation

  within 7 postoperative days

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: continuous high-frequency oscillation therapy

Control group

NO INTERVENTION

Participants in the control group will only receive standard medical, nursing, and allied healthcare, with daily decisions made without the use of protocols. This includes spontaneous breathing and awakening trials as decided by the attending intensivist, ad hoc management of pain and delirium, and once or twice daily passive and active exercises determined by the physiotherapist, with patients typically remaining in bed if on ventilation.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 years or older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jingyuan Xu, M.D.

CONTACT

8602583262550; xujingyuanmail@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2024-10