- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065428
Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure
Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine, China; Department of Critical Care Medicine St. Michaels's Hospital, University of Toronto, Canada
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 21009
- Nanjing Zhong-Da Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- We chose a number of eligible patients which were admitted to ICU of the Zhong-Da Hospital and required mechanical ventilation for more than 24 h.
Exclusion Criteria:
(1) age <18 or >85 years, (2) tracheostomy, (3) treatment abandonment, (4) history of esophageal varices, (5) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (6) coagulation disorders (INR ratio>1.5 and APTT>44 s), (7) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (8) history of leukemia, severe chronic liver or chronic cardiac disease, (9) solid organ transplantation, (10) malignant tumor
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Weaning failure
Weaning failure:(1) failed SBT; (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
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Weaning successful
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuroventilatory Efficiency (NVE)
Time Frame: at 30 minutes of the spontaneous breathing trials (SBT)
|
NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.
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at 30 minutes of the spontaneous breathing trials (SBT)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuromechanical Efficiency (NME)
Time Frame: at 30 minutes of the spontaneous breathing trials (SBT)
|
NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).
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at 30 minutes of the spontaneous breathing trials (SBT)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Haibo Qiu, MD, Phd, Southeast university
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 437129519
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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