Effects of High-Frequency Oscillatory Ventilation in ICU Patients

Physiological Effects and Safety of Continuous High-frequency Oscillatory Ventilation in ICU Patients

This study is testing whether a new breathing treatment called Continuous High-Frequency Oscillatory Ventilation can improve lung function and comfort for awake ICU patients with collapsed lungs.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Months to 80 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06702813 on ClinicalTrials.gov

What this trial studies

This interventional study evaluates the safety and efficacy of Continuous High-Frequency Oscillatory Ventilation (CHFO) in awake ICU patients suffering from atelectasis. The study aims to assess pulmonary function by comparing chest electrical impedance tomography (EIT) measurements before and after CHFO treatment. A minimum of 45 patients will be enrolled, and their vital signs and subjective comfort ratings will be collected throughout the treatment process. The goal is to determine the impact of CHFO on lung function and patient comfort in a critical care setting.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 18 to 90 with atelectasis who are alert and able to communicate.

Not a fit: Patients with severe chronic respiratory diseases or significant hemodynamic instability may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve lung function and comfort for critically ill patients with atelectasis.

How similar studies have performed: While the use of CHFO has been explored, this specific evaluation in awake critically ill patients is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Patients older than 18 and younger than 90 years;
* Admitted to the ICU after December 1, 2024, who are alert, with a GCS of 15, normal comprehension, and able to communicate clearly through speech or writing.
* Patients with atelectasis, who are receiving oxygen therapy, high-flow oxygen, or are on a ventilator via tracheostomy.
* Signed informed consent for MetaNeb treatment.

Exclusion Criteria:

* Refusal to participate in the proposed study.
* Age \< 10 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. With a clear tracheoesophageal fistula

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Shengyu Hao, PhD

Conditions: Atelectasis, Postoperative, Hypoxia, Critical Illness, HFOV, EIT, atelectasis