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Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure

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ClinicalTrials.gov Identifier: NCT01065428
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : November 16, 2010
Last Update Posted : August 31, 2011
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Respiratory Failure
Enrollment 52
Recruitment Details In a 20 beds general ICU of a teaching hospital, from December 2008 to May 2010, 52 patients , mechanically ventilated for > 24 h, were included when they deemed ready for extubation by the clinical team and fulfilled established weaning criteria.
Pre-assignment Details Nasogastric tube Eligible patient was replaced with a modified EAdi catheter (Maquet, Solna, Sweden). Then the patients were switched to a Servo-i ventilator capable of processing signals of EAdi automatically.
Arm/Group Title Weaning Failure Weaning Successful
Hide Arm/Group Description Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation. Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
Period Title: Overall Study
Started 17 35
Completed 17 35
Not Completed 0 0
Arm/Group Title Weaning Failure Weaning Successful Total
Hide Arm/Group Description Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation. Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation Total of all reporting groups
Overall Number of Baseline Participants 17 35 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 35 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
   5.9%
13
  37.1%
14
  26.9%
>=65 years
16
  94.1%
22
  62.9%
38
  73.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 35 participants 52 participants
76.0  (6.4) 65.2  (18.5) 68.8  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 35 participants 52 participants
Female
9
  52.9%
11
  31.4%
20
  38.5%
Male
8
  47.1%
24
  68.6%
32
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 17 participants 35 participants 52 participants
17 35 52
1.Primary Outcome
Title Neuroventilatory Efficiency (NVE)
Hide Description 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.
Time Frame at 30 minutes of the spontaneous breathing trials (SBT)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Weaning Failure Weaning Successful
Hide Arm/Group Description:
Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
Overall Number of Participants Analyzed 17 35
Mean (Standard Deviation)
Unit of Measure: ml/uV
17.6  (10.7) 39.9  (23.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Weaning Failure, Weaning Successful
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Neuromechanical Efficiency (NME)
Hide Description NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).
Time Frame at 30 minutes of the spontaneous breathing trials (SBT)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Weaning Failure Weaning Successful
Hide Arm/Group Description:
Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
Overall Number of Participants Analyzed 17 35
Mean (Standard Deviation)
Unit of Measure: cmH2O/uV
1.13  (0.71) 1.77  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Weaning Failure, Weaning Successful
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame During the 30 nints of SBT, and 48 hours after extubation
Adverse Event Reporting Description There was no additional intervention being used in this observational study. We just observed the NVE and NME during a local protocol of SBT and weaning. In addition to the risk caused by the routine SBT and weaning, there was no additional risk during the observation period.
 
Arm/Group Title Weaning Failure Weaning Successful
Hide Arm/Group Description Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation. Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
All-Cause Mortality
Weaning Failure Weaning Successful
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Weaning Failure Weaning Successful
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Weaning Failure Weaning Successful
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/35 (0.00%) 
Early termination leading to small numbers of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Haibo Qiu; Dr. Christer Sinderby
Organization: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine, China
Phone: 008613951965301
Responsible Party: Ling Liu, Southeast University, China
ClinicalTrials.gov Identifier: NCT01065428     History of Changes
Other Study ID Numbers: 437129519
First Submitted: February 8, 2010
First Posted: February 9, 2010
Results First Submitted: October 18, 2010
Results First Posted: November 16, 2010
Last Update Posted: August 31, 2011