Physiological Effects and Safety of Continuous High-frequency Oscillatory Ventilation in ICU Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
High-Frequency Oscillatory Ventilation
DeviceAdminister 10 minutes of high-frequency oscillatory ventilation in awake ICU patients.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: CHFO groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
EIT
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.
Time frame
Baseline, during the treatment, and at the end of the intervention (10th minute).Secondary outcomes
1
SpO2 before, during and after the CHOF treatment
The SpO2 will be measured. Measurements will be taken at three time points: (1) Within 10 minutes before the start of CHFO and (2) During the treatment, and (3)within 10 minutes after its completion.
Time frame
Baseline, during the treatment, and at the end of the intervention (10th minute).2
Mean arterial pressure
Mean arterial pressure will be measured. Measurements will be taken at three time points: (1) Within 10 minutes before the start of CHFO and (2) During the treatment, and (3)within 10 minutes after its completion.
Time frame
Baseline, during the treatment, and at the end of the intervention (10th minute).3
Comfort Rating
To have patients rate their comfort level with the treatment using the Numeric Rating Scale (NRS) after the treatment is completed.
Time frame
Within 10 minutes after the treatmentSponsors and contacts
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Source ClinicalTrials.gov