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Clinical Trials in China / NCT06702813
Recruiting Not applicable

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

NCT06702813 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2024-11-19
Last updated
2024-11-25

Condition(s) studied

Atelectasis, PostoperativeHypoxiaCritical Illness

Investigational drug(s) / intervention(s)

High-Frequency Oscillatory Ventilation

High-Frequency Oscillatory Ventilation: Administer 10 minutes of high-frequency oscillatory ventilation in awake ICU patients.

Study summary

Atelectasis, hypoxemia, and ineffective sputum clearance are common problems in ICU patients. Continuous High-Frequency Oscillation (CHFO) is often considered to have a protective effect on the lungs. CHFO provides effective gas exchange at supraphysiological frequencies while minimizing pressure fluctuations, producing tidal volumes smaller than dead space, and adjusting around a continuously expanding pressure to optimize end-expiratory lung volume (EELV), thereby improving lung function by achieving and maintaining lung recruitment. However, the physiological effects and safety of CHFO in awake critically ill patients are still lacking relevant research. The objective of this study is to evaluate the comfort, safety, and efficacy of CHFO in awake critically ill patients.

Eligibility

Sex
ALL
Min age
18 Months
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • EIT — Baseline, during the treatment, and at the end of the intervention (10th minute).
    In EIT monitoring, a 16-electrode belt was placed around the chest to record signals. Measurements will be taken at three time points: (1) within 10 minutes before the start of CHFO, (2) during the treatment, and (3) within 10 minutes after its completion.

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06702813 on ClinicalTrials.gov ↗ ← All trials in China