Atelectases, Postoperative PulmonaryNCT07284056
Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy
A study testing MetaNeb Therapy in people with Atelectases, Postoperative Pulmonary, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atelectases, Postoperative Pulmonary
- What is being tested?
- MetaNeb Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years.
- Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200030
Minhui Dong, +86 021 64041990 ext. 692959, dong.minhui@zs-hospital.sh.cn
About this study
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
- Being tested
- MetaNeb Therapy, Standard of care
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaNeb TherapyDevice
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).
Standard of careBehavioural
Standard postoperative care, including guidance on coughing and expectoration, turning and back percussion, and early mobilization (getting out of bed for physical activity).
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | Sham comparator | Not described Receives: Behavioral: Standard of care |
| MetaNeb Group | Experimental | Not described Receives: Device: MetaNeb Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2
Measured: 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
Measured: From postoperative day 1 to day 2
The difference of PaO2/FiO2 ratios on postoperative day 1 and 2
Measured: From postoperative day 1 to day 2
The number of cases that underwent bronchoscopy intervention during ICU stay
Measured: From admission to ICU discharge
The number of cases that underwent high flow oxygen therapy or mechanical ventilation
Measured: From admission to ICU discharge
Length of ICU stay
Measured: From admission to ICU discharge
The number of cases that develop pneumothorax during intervention
Measured: From admission to the end of intervention at postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectases, Postoperative PulmonaryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284056
- Sponsor's protocol ID
- KY2024847
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It might compromise the interests of MetNeb company and we still need to negotiate it further.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy
- ClinicalTrials.gov ID
- NCT07284056
- Acronym / sponsor ID
- KY2024847
- Conditions
- Atelectases, Postoperative Pulmonary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Group | Sham comparator | Behavioral: Standard of care |
| MetaNeb Group | Experimental | Device: MetaNeb Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 85 years.
- Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetaNeb TherapyPatients 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). | Device | MetaNeb Group |
| Standard of careStandard postoperative care, including guidance on coughing and expectoration, turning and back percussion, and early mobilization (getting out of bed for physical activity). | Behavioural | Standard Group |
Primary outcome
The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2
Time frame: From postoperative day 1 to day 2
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided. It might compromise the interests of MetNeb company and we still need to negotiate it further.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetaNeb Therapy in people with Atelectases, Postoperative Pulmonary, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minhui Dong (+86 02164041990 ext. 692959, dong.minhui@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2 (time frame: From postoperative day 1 to day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.