Prevention and Treatment of Early Postoperative Atelectas... | NCT07284056

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

NCT07284056

Sponsor

Shanghai Zhongshan Hospital

Status

Not yet recruiting

Last Update Posted

Dec 16, 2025Actual

Enrollment

178Estimated

Phase

Not Applicable

Conditions

Atelectases, Postoperative Pulmonary

Interventions

MetaNeb Therapy
Standard of care

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Apr 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 2, 2025

First Submission Date that Met QC Criteria

Dec 15, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2025

Last Update Posted Date

Dec 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

178Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Group	Sham Comparator		Behavioral: Standard of care
MetaNeb Group	Experimental		Device: MetaNeb Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Minhui Dong	Contact	+86 02164041990	692959	dong.minhui@zs-hospital.sh.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital Fudan University		Shanghai	Shanghai Municipality	200030	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

It might compromise the interests of MetNeb company and we still need to negotiate it further.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided