Evaluation of the efficacy of OLE application in patients at high risk of mechanical ventilation combined with atelectasis after surgery: A single center randomized controlled study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600118674

Enrollment

Unknown

Registered

2026-02-10

Start date

2026-02-15

Completion date

Unknown

Last updated

2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical ventilation after surgery combined with atelectasis

Interventions

Control group:Conventional treatment (position + turning over + sputum aspiration

Intervention Group:MetaNeb system treatment with CHFO for 10 minutes four times a day (with an interval of >=2 hours)

5ml of 0.9% sodium chloride was nebulized throughout the process

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. Mechanically ventilated; 3. Postoperative (cardiac, thoracic, or abdominal surgery); 4. ASA classification >=3 or ASA class 2 with at least one of the following: Smoking history +/- COPD history +/- BMI >=30 kg/m^2; 5. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Age <18 years; 2.Patients with absolute contraindications to MetaNeb® System therapy; 3.Patients expected to be discharged from the ICU within 72 hours; 4.Patients extubated within 3 days after study initiation; 5.Pregnancy; 6.Patients receiving ECMO therapy; 7.Patients with treatment withdrawal/comfort care (end-of-life care).

Design outcomes

Primary

Measure	Time frame
Weaning success rate (successful liberation from mechanical ventilation for more than 48 hours);	—

Secondary

Measure	Time frame
Atelectasis improvement: percentage change in CT-defined atelectasis;Change in lung volume measured by CT;EIT parameters: assessment of compliance changes (?TIV, ?EELI);EIT parameters: regional ventilation distribution (% in ROI 1/2/3/4);EIT parameters: global ventilation homogeneity/symmetry (GI, COV, RVD);Number of bronchoscopies;Vital signs (HR, BP, RR);Blood gas parameters (PaO2, PaCO2, P/F ratio) + SpO2/FiO2 ratio;Lung ultrasound score;Duration of mechanical ventilation;Ventilator-free days at 28 days;ICU mortality rate;Length of ICU stay;Hospital length of stay;In-hospital mortality at 28 days;Re-admission rate to ICU;Ventilator-associated pneumonia (VAP) incidence rate;	—

Measure

Time frame

Atelectasis improvement: percentage change in CT-defined atelectasis;Change in lung volume measured by CT;EIT parameters: assessment of compliance changes (?TIV, ?EELI);EIT parameters: regional ventilation distribution (% in ROI 1/2/3/4);EIT parameters: global ventilation homogeneity/symmetry (GI, COV, RVD);Number of bronchoscopies;Vital signs (HR, BP, RR);Blood gas parameters (PaO2, PaCO2, P/F ratio) + SpO2/FiO2 ratio;Lung ultrasound score;Duration of mechanical ventilation;Ventilator-free days at 28 days;ICU mortality rate;Length of ICU stay;Hospital length of stay;In-hospital mortality at 28 days;Re-admission rate to ICU;Ventilator-associated pneumonia (VAP) incidence rate;

—

Countries

China

Contacts

Public ContactLiu Kai

Zhongshan Hospital, Fudan University

liu.kai1@zs-hospital.sh.cn+86 13512136346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026