Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MetaNeb Therapy, Standard of care.
- Who it may be relevant to
- Registry conditions: Atelectases, Postoperative Pulmonary. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device MetaNeb Therapy
Patients 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). - Behavioral Standard of care
Standard postoperative care, including guidance on coughing and expectoration, turning and back percussion, and early mobilization (getting out of bed for physical activity).
Primary outcome measures
- The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2 [Time frame: From postoperative day 1 to day 2]
Secondary outcome measures (6)
- The difference of dorsal ventilation region assessed by electrical impedance tomography (EIT) on postoperative day 1 and 2 [Time frame: From postoperative day 1 to day 2]
- The difference of PaO2/FiO2 ratios on postoperative day 1 and 2 [Time frame: From postoperative day 1 to day 2]
- The number of cases that underwent bronchoscopy intervention during ICU stay [Time frame: From admission to ICU discharge]
- The number of cases that underwent high flow oxygen therapy or mechanical ventilation [Time frame: From admission to ICU discharge]
- Length of ICU stay [Time frame: From admission to ICU discharge]
- The number of cases that develop pneumothorax during intervention [Time frame: From admission to the end of intervention at postoperative day 2]
Eligibility criteria
Inclusion criteria
- Age between 18 and 85 years.
- Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital Fudan University — Shanghai
Identifiers
NCT: NCT07284056 · KY2024847