ClinicalTrials.gg
Not yet recruitingNCT06359977Updated Apr 11, 2024

The Effect of Quantitative EEG Combined With Ultrasound and Sputum Volume on Predicting Weaning Failure

An observational study in Weaning Failure, sponsored by Qingdao University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Qingdao University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

Neurocritical patients often face the need for removal of endotracheal tubes. However, despite following the extubation criteria for general critical ill patients, neurocritical patients still exhibit a higher rate of weaning failure, significantly higher than that of general critical ill patients. The extubation criteria for general critical patients emphasize the assessment of lung conditions. However, neurological critical patients often have less severe lung damage, but factors such as consciousness level and coughing ability may significantly influence extubation. Quantitative EEG serves as an objective tool to reflect consciousness level status, while bedside ultrasound can assess respiratory muscle function. Additionally, sputum volume may reflect the condition of lung condition. Therefore, we believe that combination of these three indicators can better predict the success of extubation for neurocritical patients.

02

Conditions studied

  • Weaning Failure

Keywords

  • Quantitative Electroencephalography
  • ultrasound
03

In context

Lead sponsor

Qingdao University is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The population in this study focused on neurocritical patients with endotracheal intubation. The data of quantitative EEG, beside ultrasound and sputum volume are all recorded for predicting weaning failure.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neurocritical patients with endotracheal intubation;
  • Successful spontaneous Breathing Trial;
  • The patients meet extubation criteria evaluated by clinical physician

Exclusion criteria

Exclusion Criteria:

  • Patients whose families have opted for cessation of treatment.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Neurocritical Patients requiring weaning

    The population in this study focused on neurocritical patients with endotracheal intubation. The data of quantitative EEG, beside ultrasound and sputum volume are all recorded for predicting weaning failure.

    Other: Quantitative EEG monitoring and beside ultrasound evaluation

Interventions

  • OtherQuantitative EEG monitoring and beside ultrasound evaluation

    After successful spontaneous breathing trial, neurocritical patients undergo at least 2 hours of quantitative EEG monitoring before extubation. Additionally, bedside ultrasound assesses the thickness and variability of the diaphragm, intercostal muscles, rectus abdominis, transversus abdominis, and external oblique muscles. The sputum volume for the 24 hours prior to extubation is also recorded. Reintubation within 48 hours after extubation is defined as weaning failure.

06

What researchers measure

Primary outcomes

  1. Quantitative EEG indicators

    These indicators including amplitude EEG and the proportion of α,β,δ,θ wave

    Time frame: 2 hours before extubation

  2. Respiratory muscles thickness in centimeter

    Muscle thickness was evaluated by ultrasound.

    Time frame: 2 hours before extubation

  3. Respiratory muscles thickening fraction (%)

    Muscle thickening fraction was evaluated by ultrasound. It equals (end-inspiratory thickness - end-expiratory thickness)/end-expiratory thickness × 100%.

    Time frame: 2 hours before extubation

  4. Sputum volume in milliliter

    The amount of sputum

    Time frame: 24 hours before extubation

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Welte TM, Gabriel M, Hopfengartner R, Rampp S, Gollwitzer S, Lang JD, Stritzelberger J, Reindl C, Madzar D, Sprugel MI, Huttner HB, Kuramatsu JB, Schwab S, Hamer HM. Quantitative EEG may predict weaning failure in ventilated patients on the neurological intensive care unit. Sci Rep. 2022 May 4;12(1):7293. doi: 10.1038/s41598-022-11196-7. PubMed 35508676 ↗
  • Bosel J. Who Is Safe to Extubate in the Neuroscience Intensive Care Unit? Semin Respir Crit Care Med. 2017 Dec;38(6):830-839. doi: 10.1055/s-0037-1608773. Epub 2017 Dec 20. PubMed 29262440 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2024; primary completion for Apr 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2024
First posted
Apr 11, 2024
StartEst.
Apr 15, 2024
Primary completionEst.
Apr 15, 2025
CompletionEst.
May 15, 2025
Last update
Apr 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06359977
Lead sponsor
Qingdao University
Responsible party
Bo Yao,phD (The department of critical care medicine, Affiliated hospital of Qingdao university, Qingdao University) — Principal investigator
First posted
Apr 11, 2024
Start date
Apr 15, 2024 (estimated)
Primary completion
Apr 15, 2025 (estimated)
Completion
May 15, 2025 (estimated)
Last update
Apr 11, 2024

Study contacts

bo yao, Dr.
Contact
icuyaobo@126.com
+8618661800691
bo yao, Dr.
principal investigator · The Affiliated Hospital of Qingdao University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion