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

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: Not yet recruiting
• Conditions: Weaning Failure
• Intervention / Treatment: Other: Quantitative EEG monitoring and beside ultrasound evaluation

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: bo yao, Dr.; Phone Number: +8618661800691; Email: icuyaobo@126.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qingdao University
• Investigators: Principal Investigator: bo yao, Dr., The Affiliated Hospital Of Qingdao University

Publications and helpful links

General 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.
• 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 record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; Quantitative Electroencephalography
• Other Study ID 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