NCT03433105

Brief Summary

1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase.

  1. 1.Patient: who have tracheostomy tubes and with prolonged mechanical ventilation
  2. 2.Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous breathing trials
  3. 3.Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome
  4. 4.to investigate the prognostic value of oxygen uptake in weaning patients from prolonged mechanical ventilation
  5. 5.Subgroup analysis may suggest which weaning protocol potentially benefit the most for each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular disease, cerebrovascular disease)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 23, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2020

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2019

Enrollment Period

2.6 years

First QC Date

January 23, 2018

Last Update Submit

October 6, 2020

Conditions

Keywords

oxygen uptakeprolonged mechanical ventilationweaning

Outcome Measures

Primary Outcomes (1)

  • Measurement of oxygen uptake (V̇O2)

    oxygen uptake during the spontaneous breathing trial

    up to 12 hours during the spontaneous breathing trial

Study Arms (1)

1/patients with tracheostomy tubes and prolonged MV use

Patients who have tracheostomy tubes and with prolonged mechanical ventilation

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient who have tracheostomy tubes and with prolonged mechanical ventilation

You may qualify if:

  • Adult \>20 y/o Total duration of mechanical ventilation ≥ 10 days Received tracheostomy Defervescence Meeting the criteria of weaning phase (see supplementary protocols)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Yao-Wen Kuo, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 14, 2018

Study Start

January 23, 2018

Primary Completion

August 14, 2020

Study Completion

August 14, 2020

Last Updated

October 8, 2020

Record last verified: 2019-09

Locations