Effects of High-Frequency Oscillatory Ventilation on ICU Patients

Assessing the Physiological Impact and Safety of Continuous High-Frequency Oscillatory Ventilation in Critically Ill Patients Under Mechanical Ventilation

This study is testing if a special type of breathing support called Continuous High-Frequency Oscillatory Ventilation can help critically ill patients on ventilators breathe better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 20 Years to 90 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06662630 on ClinicalTrials.gov

What this trial studies

This interventional study evaluates the safety and efficacy of Continuous High-Frequency Oscillatory Ventilation (CHFO) in critically ill patients on mechanical ventilation. It aims to assess the physiological effects of CHFO on lung function by comparing pulmonary parameters before and after treatment. The study will enroll at least 30 patients who are intubated and unable to be extubated within 48 hours due to conditions like Acute Respiratory Distress Syndrome, atelectasis, or Ventilator-Associated Pneumonia. Measurements will include end-expiratory lung volume and chest electrical impedance tomography to determine the impact of CHFO on lung recruitment and gas exchange.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who are intubated and expected to require mechanical ventilation for more than 48 hours due to specific respiratory conditions.

Not a fit: Patients with severe chronic respiratory diseases requiring long-term oxygen therapy or those expected to be extubated within 48 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve lung function and reduce complications associated with mechanical ventilation in critically ill patients.

How similar studies have performed: While the use of high-frequency oscillatory ventilation has been explored, this specific approach and its physiological effects in this patient population are relatively novel.

Eligibility criteria

Inclusion Criteria:

* Patients older than 18 and younger than 90 years;
* Admitted to the ICU after October 15, 2024, who are intubated and expected to be unable to be extubated within 48 hours due to ARDS, or have atelectasis, or have VAP.
* Signed informed consent for MetaNeb treatment.

Exclusion Criteria:

* Refusal to participate in the proposed study.
* Age \< 20 years;
* Pregnancy;
* Significant hemodynamic instability defined as an increase of more than 20% in catecholamine doses in the last hour, despite optimization of blood volume, for a target mean blood pressure between 65 and 75 mmHg.
* Participation in another trial within 30 days prior to meeting eligibility criteria;
* Severe chronic respiratory disease requiring long-term oxygen therapy or home mechanical ventilation;
* Pneumothorax;
* Expected duration of mechanical ventilation \< 48 hours
* Decision to refuse life-sustaining treatment.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shengyu Hao, Ph.D

Conditions Atelectasis; Acute Respiratory Distress Syndrome; VAP - Ventilator Associated Pneumonia; mechanical ventilation; HFOV; EIT; FRC