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Search / Trial NCT06662630

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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Oct 26, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Mechanical Ventilation Hfov Eit Frc

ClinConnect Summary

This clinical trial is studying a new method of breathing support called Continuous High-Frequency Oscillation (CHFO) for patients who are on mechanical ventilation in the intensive care unit (ICU). Mechanical ventilation helps patients breathe when they are very ill, but it can sometimes cause problems like lung infections or damage. The researchers want to find out if CHFO is safe and effective for helping these patients, especially for those dealing with conditions like acute respiratory distress syndrome (ARDS), atelectasis (when part of the lung collapses), or ventilator-associated pneumonia (a type of lung infection).

To participate in this study, patients need to be between 18 and 90 years old and must be in the ICU on a ventilator for at least 48 hours due to their serious lung issues. They should also be able to give permission for this treatment. If someone joins the study, they will receive CHFO as part of their care, and the team will monitor their health closely. It's important to note that not everyone can participate; for example, those under 20, pregnant women, or patients with certain severe health conditions will not be included. The goal is to better understand how CHFO might help improve the care of critically ill patients on mechanical ventilation.

Gender

ALL

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.

About Shanghai Zhongshan Hospital

Shanghai Zhongshan Hospital is a prestigious medical institution affiliated with Fudan University, renowned for its commitment to advancing healthcare through rigorous clinical research and innovative patient care. With a focus on multidisciplinary collaboration and cutting-edge medical technologies, the hospital conducts a wide range of clinical trials aimed at improving treatment outcomes across various specialties. Its state-of-the-art facilities and highly qualified research team ensure that trials adhere to the highest ethical and scientific standards, contributing significantly to the global body of medical knowledge and enhancing patient health outcomes.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Jian Zhou, PhD

Study Director

Fudan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported