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Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065428
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : November 16, 2010
Last Update Posted : August 31, 2011
Unity Health Toronto
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

Brief Summary:
The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully extubated and those who failed weaning.

Condition or disease
Respiratory Failure

Detailed Description:
Patients, mechanically ventilated for > 24 h, were included when they met criteria for their first spontaneous breathing trial (SBT) on continuous positive airway pressure (CPAP) (5-6 cmH2O) for 30 minutes. Patients who did not fulfill the criteria for successful SBT, or required assist, or deceased within 48h post-extubation were considered extubation failure (F). Patients who completed the SBT and remained extubated > 48 h were considered successfully extubated (S). Before and during the SBT, arterial blood gases, heart, rate, blood pressure, and EAdi, flow, Vt, f, and, airway pressure (Paw) were measured. At 0, 5, 10, 15 and 30 minutes of the SBT, f/Vt, diaphragm electrical activity (EAdi), NME, and NVE were calculated. NME was calculated as Paw/EAdi during inspiratory occlusion. NVE was calculated as Vt/EAdi during unassisted inspirations.Arterial blood gases, heart rate, and blood pressure were measured. The receiver operating characteristic (ROC) curve was calculated to evaluate the predictive performance of each index.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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 Start Date : December 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Weaning failure
Weaning failure:(1) failed SBT; (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
Weaning successful
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Biospecimen Retention:   Samples Without DNA
Parameters of arterial blood gases, haemodynamic and mechanics of breathing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who required mechanical ventilation for more than 24 h.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065428

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China, Jiangsu
Nanjing Zhong-Da Hospital
Nanjing, Jiangsu, China, 21009
Sponsors and Collaborators
Southeast University, China
Unity Health Toronto
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Study Director: Haibo Qiu, MD, Phd Southeast University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ling Liu, Prof., Southeast University, China Identifier: NCT01065428    
Other Study ID Numbers: 437129519
First Posted: February 9, 2010    Key Record Dates
Results First Posted: November 16, 2010
Last Update Posted: August 31, 2011
Last Verified: August 2011
Keywords provided by Ling Liu, Southeast University, China:
neuromechanical efficiency
neuroventilatory efficiency
Respiration, Artificial
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases