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Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure

This study has been completed.
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Ling Liu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01065428
First received: February 8, 2010
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Phase
Respiratory Failure
 Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Neuroventilatory Efficiency (NVE) [ Time Frame: at 30 minutes of the spontaneous breathing trials (SBT) ] [ Designated as safety issue: No ]
    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:
  • Neuromechanical Efficiency (NME) [ Time Frame: at 30 minutes of the spontaneous breathing trials (SBT) ] [ Designated as safety issue: No ]
    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


Enrollment: 52
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who required mechanical ventilation for more than 24 h.

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065428

Locations
China, Jiangsu
Nanjing Zhong-Da Hospital
Nanjing, Jiangsu, China, 21009
Sponsors and Collaborators
Southeast University, China
St. Michael's Hospital, Toronto
Investigators
Study Director: Haibo Qiu, MD, Phd Southeast University
  More Information

No publications provided

Responsible Party: Ling Liu, Prof., Southeast University, China
ClinicalTrials.gov Identifier: NCT01065428     History of Changes
Other Study ID Numbers: 437129519
Study First Received: February 8, 2010
Results First Received: October 18, 2010
Last Updated: August 29, 2011
Health Authority: China: Ethics Committee

Keywords provided by Southeast University, China:
neuromechanical efficiency
neuroventilatory efficiency
weaning
Respiration, Artificial

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013