About this trial
The goal of this clinical trial is to evaluate whether the MetaNeb® System can effectively prevent and treat early postoperative atelectasis in adult patients admitted to ICU after esophagectomy for esophageal cancer.
The main question it aims to answer is: can the MetaNeb® system significantly reduce the lung ultrasound score (LUSS) indicating atelectasis on postoperative days 1 and 2? Participants will be randomly assigned to either the standard treatment or MetaNeb group, undergo lung ultrasound and electrical impedance tomography (EIT) assessments on postoperative days 1 and 2, receive at least 4 sessions of MetaNeb therapy on postoperative day 1 if in the intervention group, be monitored for oxygenation indices, ICU stay duration, incidence of mechanical ventilation, need for bronchoscopic intervention, and adverse events like pneumothorax.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 85 years.
Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.
Disqualifiers
Presence of an artificial airway at the time of ICU admission.
Planned ICU stay less than 24 hours.
Patients with contraindications to the use of the MetaNeb® System, or those unable to cooperate due to organic or psychiatric conditions.
Trial design
Parallel
Treatments tested in this trial
MetaNeb Therapy
DevicePatients in the MetaNeb group receive at least 4 sessions of MetaNeb therapy on postoperative day 1 (each session includes cycles of CPEP and CHFO modes totaling 10 minutes).
Standard of care
BehavioralStandard postoperative care, including guidance on coughing and expectoration, turning and back percussion, and early mobilization (getting out of bed for physical activity).
Treatment groups
Trial outcomes
Primary outcomes
The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2
Secondary outcomes
The difference of dorsal ventilation region assessed by electrical impedance tomography (EIT) on postoperative day 1 and 2
The difference of PaO2/FiO2 ratios on postoperative day 1 and 2
The number of cases that underwent bronchoscopy intervention during ICU stay
The number of cases that underwent high flow oxygen therapy or mechanical ventilation
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: