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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06359977
Other study ID # YB-202442
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2024
Est. completion date May 15, 2025

Study information

Verified date April 2024
Source Qingdao University
Contact bo yao, Dr.
Phone +8618661800691
Email icuyaobo@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 15, 2025
Est. primary completion date April 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qingdao University

References & Publications (2)

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. — View Citation

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 i — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative EEG indicators These indicators including amplitude EEG and the proportion of a,ß,d,? wave 2 hours before extubation
Primary Respiratory muscles thickness in centimeter Muscle thickness was evaluated by ultrasound. 2 hours before extubation
Primary 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
Primary Sputum volume in milliliter The amount of sputum 24 hours before extubation
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