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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 85 years.

Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Standard GroupSham comparator 1 intervention
Group B: MetaNeb GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From postoperative day 1 to day 2

Secondary outcomes

1

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
2

The difference of PaO2/FiO2 ratios on postoperative day 1 and 2

Time frame
From postoperative day 1 to day 2
3

The number of cases that underwent bronchoscopy intervention during ICU stay

Time frame
From admission to ICU discharge
4

The number of cases that underwent high flow oxygen therapy or mechanical ventilation

Time frame
From admission to ICU discharge

Other outcomes

Sponsors and contacts

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