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

NCT07003672 | Recruiting

• 1 other identifier: 202401042RINB
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This project focuses on the analysis of the correlation between transpulmonary driving pressure and uneven lung ventilation and regional lung compliance in patients using prolonged mechanical ventilation (PMV), in order to understand the clinical occurrence of failure of the final spontaneous breathing test and inability to breathe. Respiratory physiology impairments in patients successfully discharged from respirators.

Conditions

Weaning Failure

Keywords

prolonged mechanical ventilation，PMV; chronic critical illness，CCI

Outcome Measures

Primary Outcomes (1)

• SIMV+PSV（Synchronized intermittent mandatory ventilation + pressure support ventilation)

  Timing points for measurement in respiratory physiology assessment include: 1) once when the ventilator is reduced to the lowest supported SIMV+PV mode, and once in the first and fourth hours of the four-hour weaning test period (collar mask), for a total of three times. The measurement tools were the EIT measuring instrument (PulmoVista 500, Dräger Medical, Lübeck, Germany) and the IC measuring instrument Engström Carestation (GE Healthcare, Madison, WI, USA) available in the Department of Respiratory Therapy of our hospital. The methods for measuring EIT 62,64 and IC 57 were as described in the literature30. Tubes will also be installed and connected to the instruments provided by the respiratory therapy department. The esophageal pressure measurement tube is an esophageal balloon similar to a nasogastric tube. The esophageal balloon used in this study has two functions of pressure measurement and nasogastric tube (Nutrivent®), which can be placed for 30 days and has the function of

  ．up to 16 weeks

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project hopes to conduct research on patients on prolonged ventilator use (PMV). This group is an important manifestation of chronic severe illness and prolonged use of respirators after acute illness.

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Central Study Contacts

Jih-Shuin Jerng, MD, PhD, Principal Investigator

CONTACT

+886-2-23123456; jsjerng@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: June 4, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)