Actively Recruiting

Phase Not Applicable
Age: 20Years - 90Years
All Genders
ID06662630

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

Led by Shanghai Zhongshan Hospital · Updated on 2024-11-20

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the physiological effects and safety of Continuous High-Frequency Oscillation (CHFO) in critically ill patients who require mechanical ventilation. This study aims to assess how CHFO impacts lung function and other pathophysiological parameters in patients with conditions such as acute respiratory distress syndrome, atelectasis, and ventilator-associated pneumonia. The study addresses the lack of research on the safety and benefits of CHFO in such patients. Participants will receive treatment using the CHFO machine (MetaNeb system) while undergoing invasive mechanical ventilation. The treatment involves applying CHFO continuously for 10 minutes to improve lung volume and gas exchange. Before, during, and after the intervention, researchers will collect data including ventilatory parameters, heart rate, blood pressure, and arterial blood gases. The procedure also involves placing an electrical impedance tomography (EIT) belt to monitor lung volume changes. During the study, patients will be closely monitored with continuous data recording using the EIT device and regular collection of physiological measurements. The primary outcomes measured are changes in end-expiratory lung volume and chest electrical impedance tomography values at the start and end of CHFO treatment. Secondary outcomes include central venous pressure, oxygenation ratios, plateau pressure, mean arterial pressure, and adverse events. The total intervention duration is 10 minutes with data collected before, during, and 30 minutes after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 and younger than 90 years
  • Admitted to the ICU after October 15, 2024, who are intubated and expected to require mechanical ventilation for more than 48 hours due to acute respiratory distress syndrome, atelectasis, or ventilator-associated pneumonia
  • Signed informed consent for MetaNeb treatment
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 30 minutes

Participants receive 10 minutes of high-frequency oscillatory ventilation using the CHFO machine (MetaNeb system) while mechanically ventilated. Measurements of lung volume, ventilatory parameters, blood gases, heart rate, and blood pressure are collected before, during, and after the treatment.

1 treatment session

Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200030

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Research Team

S

Shengyu Hao, Ph.D

Y

Yuxian Wang, B.S

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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