How differences in lung stiffness and breathing pressures affect getting off the ventilator after a tracheostomy

Role of Regional Lung Compliance and Dynamic Transpulmonary Driving Pressure in the Liberation Difficulty in Tracheostomized Patients Receiving Prolonged Mechanical Ventilation

This project will test whether measurements of regional lung compliance and transpulmonary driving pressure using electrical impedance tomography and esophageal pressure can explain why some tracheostomized patients on prolonged mechanical ventilation cannot be weaned.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT07003672 on ClinicalTrials.gov

What this trial studies

This observational project will enroll adult tracheostomized patients who have been on mechanical ventilation for at least 14 days in the subacute respiratory care ward at National Taiwan University Hospital. Participants will undergo electrical impedance tomography (EIT) and esophageal pressure measurements to quantify regional lung compliance, overinflation or collapse, and transpulmonary driving pressure during weaning and spontaneous breathing trials. Researchers will correlate pixel-level compliance changes and measured pressures with failure of the final spontaneous breathing test and difficulty liberating from the ventilator. The aim is to identify respiratory physiology markers that predict weaning failure and to inform individualized ventilation or rehabilitation strategies for prolonged mechanical ventilation patients.

Who should consider this trial

Good fit: Ideal candidates are adults (≥20 years) with a tracheostomy who have required mechanical ventilation for at least 14 days, require FiO2 ≤50%, and are managed in the NTUH subacute respiratory ward.

Not a fit: Patients with active COPD or asthma, unstable vital signs requiring continuous vasopressors, pregnancy, contraindications to esophageal balloon placement, or implanted cardiac rhythm devices are unlikely to benefit or cannot participate.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify patients at high risk of weaning failure and tailor ventilation or rehabilitation strategies to improve chances of liberation.

How similar studies have performed: EIT and transpulmonary pressure monitoring have been used in acute respiratory failure and some weaning research, but applying these tools specifically to prolonged mechanical ventilation and tracheostomy liberation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Post-tracheostomy patients who are transferred to the subacute respiratory care ward of National Taiwan University Hospital must use respirators for at least 14 days;
* Be at least 20 years old;
* The oxygen concentration required when using the respirator does not exceed 50%

Exclusion Criteria:

* The vital signs are unstable or require continuous use of vasopressors;
* Pregnancy;
* Chronic obstructive pulmonary disease or asthma;
* Those who have contraindications to the placement of esophageal pressure balloons, such as abnormal blood coagulation, esophageal varices, and those who have undergone esophageal or gastric surgery in the past six months;
* Those who have contraindications to the use of electrical impedance tomography, such as heart rhythm regulators.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Jih-Shuin Jerng, MD, PhD, Principal Investigator

Conditions Weaning Failure; prolonged mechanical ventilation，PMV; chronic critical illness，CCI