NCT05634135

Brief Summary

This project will conduct a series of analysis of physiological and clinical data on tracheostomy patients who receive prolonged mechanical ventilation, hoping to find out the different manifestations of patients through the investigation by a variety of physiologic measurements, so as to understand whether different types of patients phenotype to derive different clinical strategies for liberation of the mechanical ventilator.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
Last Updated

December 30, 2024

Status Verified

September 1, 2024

Enrollment Period

2.6 years

First QC Date

November 21, 2022

Last Update Submit

December 26, 2024

Conditions

Keywords

Ventilationmechanical ventilationweaningoxygen uptake

Outcome Measures

Primary Outcomes (1)

  • Liberation from mechanical ventilation at discharge from the weaning unit

    At least five consecutive days of free from mechanical ventilation ventilation

    Five days

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic critically ill patients receiving prolonged mechanical ventilation

You may qualify if:

  • Patients with at least 10 days of mechanical ventilation at the intensive care unit of National Taiwan University Hospital and transferred to the Respiratory Care Center of National Taiwan University Hospital for weaning training
  • Patients who have undergone tracheostomy and still have a tracheotomy tube
  • Are at least 20 years old
  • Stable respiratory condition with inspired oxygen fraction not exceeding 50%

You may not qualify if:

  • Hemodynamic instability or continuous use of vasopressors
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jih-Shuin Jerng, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jih-Shuin Jerng, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 1, 2022

Study Start

July 31, 2022

Primary Completion

February 17, 2025

Study Completion

February 17, 2025

Last Updated

December 30, 2024

Record last verified: 2024-09

Locations