NCT06359977

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet 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

First Submitted

Initial submission to the registry

April 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 2, 2024

Last Update Submit

April 7, 2024

Conditions

Keywords

Quantitative Electroencephalographyultrasound

Outcome Measures

Primary Outcomes (4)

  • Quantitative EEG indicators

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

    2 hours before extubation

  • Respiratory muscles thickness in centimeter

    Muscle thickness was evaluated by ultrasound.

    2 hours before extubation

  • Respiratory muscles thickening fraction (%)

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

    2 hours before extubation

  • Sputum volume in milliliter

    The amount of sputum

    24 hours before extubation

Study Arms (1)

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

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.

Neurocritical Patients requiring weaning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients whose families have opted for cessation of treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • bo yao, Dr.

    The Affiliated Hospital of Qingdao University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The department of critical care medicine, Affiliated hospital of Qingdao university

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 11, 2024

Study Start

April 15, 2024

Primary Completion

April 15, 2025

Study Completion

May 15, 2025

Last Updated

April 11, 2024

Record last verified: 2024-04