Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
NCT Number: NCT06702813
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.
Interested in participating?
Request Info18 month–80 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
This is an interventional study evaluating the beneficial impact of CHFO (Continuous High Frequency Oscillatory Ventilation) in awake ICU patients with atelectasis on ventilatory function.
This therapeutic study aims to treat patients using the CHFO machine (MetaNeb system). The study involves comparing pulmonary pathophysiological parameters before and after CHFO treatment in awake patients with atelectasis.
The primary outcome is the difference in chest electrical impedance tomography (EIT) measurements taken at the end of CHFO treatment (10 minutes) compared to the baseline value measured at the beginning of the protocol.
The minimum number of subjects to enroll in this study is 45 patients. Intermediate analyses are planned after every 5 patients to reassess the required number of patients.
Baseline data collected at the beginning of the protocol include pulse oximetry and measurements of heart rate and blood pressure. During the treatment, pulse oximetry and measurements of heart rate and blood pressure will be collected. At the end of the treatment, arterial blood gas analysis, heart rate, and blood pressure will be measured. EIT data will be collected at 10 minutes before the start of CHFO, during treatment, and 10 minutes after the treatment. At the end of the treatment, collect patients' subjective ratings of treatment comfort.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administer 10 minutes of high-frequency oscillatory ventilation in awake ICU patients.
Time frame: 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.
Time frame: Baseline, during the treatment, and at the end of the intervention (10th minute).
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).
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: Within 10 minutes after the treatment
To have patients rate their comfort level with the treatment using the Numeric Rating Scale (NRS) after the treatment is completed.
Contact information is provided by the study sponsor or research team.
Shanghai Zhongshan Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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