Atelectases, Postoperative Pulmonary
Conditions
Brief summary
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
DEVICEMetaNeb 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).
BEHAVIORALStandard 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).
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 85 years. 2. Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.
Exclusion criteria
1. Presence of an artificial airway at the time of ICU admission. 2. Planned ICU stay less than 24 hours. 3. Patients with contraindications to the use of the MetaNeb® System, or those unable to cooperate due to organic or psychiatric conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2 | From postoperative day 1 to day 2 |
Secondary
| Measure | Time frame |
|---|---|
| The difference of PaO2/FiO2 ratios on postoperative day 1 and 2 | From postoperative day 1 to day 2 |
| The number of cases that underwent bronchoscopy intervention during ICU stay | From admission to ICU discharge |
| The difference of dorsal ventilation region assessed by electrical impedance tomography (EIT) on postoperative day 1 and 2 | From postoperative day 1 to day 2 |
| Length of ICU stay | From admission to ICU discharge |
| The number of cases that develop pneumothorax during intervention | From admission to the end of intervention at postoperative day 2 |
| The number of cases that underwent high flow oxygen therapy or mechanical ventilation | From admission to ICU discharge |
Countries
China
Contacts
Primary ContactMinhui Dong
Outcome results
None listed