Actively Recruiting

Phase Not Applicable
Age: 18Months - 80Years
All Genders
ID06702813

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

Led by Shanghai Zhongshan Hospital · Updated on 2024-11-25

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the comfort, safety, and effectiveness of Continuous High-Frequency Oscillation (CHFO) in awake critically ill patients with atelectasis. CHFO is a device-based therapy that aims to improve lung function by maintaining lung recruitment and optimizing gas exchange at high frequencies with minimal pressure changes. This interventional study focuses on ICU patients who experience common respiratory problems like atelectasis, hypoxemia, and poor sputum clearance. The study involves using the CHFO machine (MetaNeb system) to provide 10 minutes of high-frequency oscillatory ventilation in awake patients. Before treatment, a belt for electrical impedance tomography (EIT) is placed to monitor lung function continuously before, during, and after the intervention. Key measurements such as pulse oximetry, heart rate, blood pressure, and arterial blood gas analysis are collected at baseline, throughout treatment, and after the session. Patients also provide subjective ratings of their comfort following the treatment. Participants will be closely monitored with EIT data collected 10 minutes before, during, and 10 minutes after CHFO therapy, alongside vital signs and oxygen levels. The main outcome is the change in lung function assessed by EIT at the end of treatment compared to baseline. Secondary outcomes include oxygen saturation, blood pressure, and patient comfort ratings. The study plans to enroll at least 45 patients with interim analyses after every 5 enrollments to adjust recruitment needs. The total participation includes preparation, treatment, and follow-up assessments within a short timeframe during ICU care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Months - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged older than 18 and younger than 90 years
  • Admitted to the ICU after December 1, 2024, who are alert with a Glasgow Coma Scale of 15 and able to communicate clearly
  • Patients with atelectasis receiving oxygen therapy, high-flow oxygen, or ventilated via tracheostomy
  • Signed informed consent for MetaNeb treatment
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Age less than 10 years
  • Pregnancy
  • Significant hemodynamic instability with catecholamine dose increase over 20% in the last hour despite blood volume optimization
  • Participation in another trial within 30 days before eligibility
  • Severe chronic respiratory disease needing long-term oxygen or home mechanical ventilation
  • Pneumothorax or clear tracheoesophageal fistula

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 - 10 minutes

Participants receive 10 minutes of continuous high-frequency oscillatory ventilation using the CHFO machine (MetaNeb system) while awake in the ICU. Pulmonary and physiological measurements are collected before, during, and after the treatment.

1 treatment session with continuous monitoring

Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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Research Team

S

Shengyu Hao, PhD

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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