Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atelectases, Postoperative Pulmonary
• Intervention / Treatment: Behavioral: Standard of care; Device: MetaNeb Therapy

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minhui Dong; Phone Number: 692959 +86 02164041990; Email: dong.minhui@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • ZhongShan Hospital FuDan University
      • Contact: Minhui Dong; Phone Number: 692959 +86 021 64041990; Email: dong.minhui@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Standard Group	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).
Experimental: MetaNeb Group	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).

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
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 number of cases that underwent high flow oxygen therapy or mechanical ventilation	From admission to ICU discharge
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: KY2024847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It might compromise the interests of MetNeb company and we still need to negotiate it further.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No