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

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Fudan University

Status

Not yet enrolling

Conditions

Atelectases, Postoperative Pulmonary

Treatments

Device: MetaNeb Therapy
Behavioral: Standard of care

Study type

Interventional

Funder types

Other

Identifiers

NCT07284056
KY2024847

Details and patient eligibility

About

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.

Enrollment

178 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

178 participants in 2 patient groups

Standard Group
Sham Comparator group
Treatment:
Behavioral: Standard of care
MetaNeb Group
Experimental group
Treatment:
Device: MetaNeb Therapy

Trial contacts and locations

1

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Central trial contact

Minhui Dong

Data sourced from clinicaltrials.gov

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