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

April 7, 2024 updated by: Bo Yao,phD, Qingdao University

The Effect of Quantitative Electroencephalography Combined With Ultrasound and Sputum Volume on Predicting Weaning Failure in Neurocritical Patients

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.

Study Overview

Status

Status

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Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

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Observational

Enrollment (Estimated)

Enrollment

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50

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Study Contact

Study Contact

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Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients whose families have opted for cessation of treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantitative EEG indicators
Time Frame: 2 hours before extubation
These indicators including amplitude EEG and the proportion of α，β，δ，θ wave
2 hours before extubation
Respiratory muscles thickness in centimeter
Time Frame: 2 hours before extubation
Muscle thickness was evaluated by ultrasound.
2 hours before extubation
Respiratory muscles thickening fraction (%)
Time Frame: 2 hours before extubation
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
Time Frame: 24 hours before extubation
The amount of sputum
24 hours before extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qingdao University

Investigators

Investigators

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  • Principal Investigator: bo yao, Dr., The Affiliated Hospital of Qingdao University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YB-202442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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