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Ventilator WeaningNCT03842280

Assessments of Diaphragm-pleural Mechanics During the Weaning From Prolonged Mechanical Ventilation

An observational study of Ventilator Weaning and Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Weaning failure from mechanical ventilator is commonly seen in respiratory failure and increases duration of ventilator use, ICU stay, ventilator associated pneumonia and even mortality. The diaphragm serves as one of the most important respiratory mechanism and its function differs the weaning success rate. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Ventilator Weaning, Respiratory Failure
What is being tested?
Diaphragm ultrasound assessment & Esophageal pressure measurement
Type of treatment
Medical device
How many people
200 participants
Where
1 siteTaiwan
Study dates
1 Feb 2019to 31 Dec 2021
How long will I take part?
4 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with prolonged mechanical ventilation with tracheostomy tube with admission to respiratory care center in NTUH

Who may be able to join

  • Prolonged mechanical ventilation with tracheostomy tube
  • Oxygen with a fraction of ≤ 0.4
  • Positive end expiratory pressure at ≤ 5 cm H2O
  • Pressure support at ≤ 8 cmH2O

Who cannot join

  • No spontaneous breathing
  • Unstable hemodynamic status,
  • History of peritonitis, intraabdominal operation, empyema, or pleurodesis.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei

    Chang-Wei Wu, MD, +886952532943, sinceadidas@hotmail.com

    Recruiting

Other trials in Taiwan

About this study

Weaning failure from mechanical ventilator is commonly seen in respiratory failure and increases duration of ventilator use, ICU stay, ventilator associated pneumonia and even mortality. The diaphragm serves as one of the most important respiratory mechanism and its function differs the weaning success rate. Since 1980s, ultrasonography assessment in diaphragm movement were developed and further discussion upon whether it serves as a predicting factor for extubation failure. The measurement includes difference of diaphragm thickness, diaphragm excursion or the movement of liver and spleen.

Multiple studies targeted intubated patients with different measurement methods and all resulted with good weaning prediction value.6 Of all the studies, only one study targeted tracheostomy tube patients. They reported diaphragm thickness fraction >36% as cutoff value is associated with successful spontaneous breathing trial (SBT), with a sensitivity of 0.82, specificity of 0.88. However, little comparison with traditional weaning parameters was mentioned in the study. We designed this prospective observational study to evaluate whether diaphragm movement under ultrasound serves as a predicting index of ventilator discontinuation in patients with tracheostomy. The diaphragm movement will also correlate with other parameters such as RSBI, Pi max, Pe max, Tv spont., WEANSNOW score(WS), VO2, APACHE II. Esophageal pressure is also provided as an option for our study population for more information such as pleural pressure, transdiaphragm pressure, etc.

Read more

The ultrasonography measurement of diaphragm movement will be performed within 6 hours before discontinuation of ventilator. The patient remains in semi-recumbent position with the convex probe selected for its good penetration. The probe is placed at a craniocaudal axis, 90 degrees to the skin at the lower intercostal spaces to right anterior axillary line (AAL) and left posterior axillary line (PAL), which allows a perpendicular ultrasound beam direction to the diaphragm movement. Liver (border or vascular structure), splenic (border or vascular structure) will be selected as target point and the marked distance of movement during quiet respiration cycle will be measured 10 times with a largest value calculated. Other echo measurements will also be attempted.

The study aims to investigate if the measurement of the diaphragm movement serves as a reliable predicting factor for weaning failure in respiratory care center patients.

Being tested
Diaphragm ultrasound assessment & Esophageal pressure measurement
Keywords
Prolonged mechanical ventilation, Esophageal pressure, Pleural pressure
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diaphragm ultrasound assessment & Esophageal pressure measurementDevice

    Diaphragm ultrasound assessment and/or Esophageal pressure measurement before, during and after spontaneous breathing trial

Study groups in NCT03842280
Study groupRoleWhat they receive
Prolonged mechanical ventilationProlonged mechanical ventilation with tracheostomy
Receives: Device: Diaphragm ultrasound assessment & Esophageal pressure measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weaning success

    Liberation from mechanical ventilation

    Measured: 1 month

Secondary outcomes (3)
  1. Ventilator free 30 days after liberation

    No mechanical ventilation use in 30 days after liberation

    Measured: 30 days after liberation

  2. Ventilator free 60 days after liberation

    No mechanical ventilation use in 30 days after liberation

    Measured: 60 days after liberation

  3. Ventilator free 90 days after liberation

    No mechanical ventilation use in 90 days after liberation

    Measured: 90 days after liberation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start1 Feb 2019
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
4 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT03842280
Sponsor's protocol ID
201811015RINA
Status last verified
Mar 2020
First submitted
12 Feb 2019
Last updated
25 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ventilator Weaning and Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weaning success (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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