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

NCT07284056 | Not Yet Recruiting

• 1 other identifier: KY2024847
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectases, Postoperative Pulmonary

Outcome Measures

Primary Outcomes (1)

• The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2

  From postoperative day 1 to day 2

Secondary Outcomes (6)

• 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

Study Arms (2)

Standard Group

SHAM COMPARATOR

Behavioral: Standard of care

MetaNeb Group

EXPERIMENTAL

Device: MetaNeb Therapy

Interventions

MetaNeb Therapy DEVICE

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).

MetaNeb Group

Standard of care BEHAVIORAL

Standard postoperative care, including guidance on coughing and expectoration, turning and back percussion, and early mobilization (getting out of bed for physical activity).

Standard Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 85 years.
• Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Minhui Dong

CONTACT

+86 02164041990; dong.minhui@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)