We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation

This study has been terminated.
(Slow recruitment of subjects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00606554
First Posted: February 4, 2008
Last Update Posted: December 11, 2017
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.
Information provided by (Responsible Party):
Boston Medical Center
Results First Submitted: February 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Respiratory Insufficiency
Interventions: Device: Computer-assisted weaning program
Behavioral: Standard of Care weaning

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment start 1/2008 recruitment end: 5/2010 Recruited from Medical Intensive Care Unites Boston medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Computer-assisted Wean Group assigned to the computer-assisted weaning program Intervention Group
Standard of Care

Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Comparator group


Participant Flow:   Overall Study
    Computer-assisted Wean   Standard of Care
STARTED   15   18 
COMPLETED   15   18 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Computer-assisted Wean Group assigned to the computer-assisted weaning program Intervention Group
Standard of Care

Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Comparator group

Total Total of all reporting groups

Baseline Measures
   Computer-assisted Wean   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   18   33 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (21)   60.5  (15.5)   55.7  (18.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  33.3%      7  38.9%      12  36.4% 
Male      10  66.7%      11  61.1%      21  63.6% 
APACHE II Score [1] 
[Units: Score]
Mean (Standard Deviation)
 23.3  (7.7)   26.5  (7.1)   25  (7.4) 
[1] Acute Physiology and Chronic Health Evaluation Score Range 0-72 Higher score indicates more severe illness


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Duration of Weaning   [ Time Frame: Continuous (median weaning duration was 2 days) ]

2.  Secondary:   Duration of ICU Stay   [ Time Frame: from start of weaning to discharge from ICU, on average 1-2 weeks ]

3.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days ]

4.  Secondary:   Duration of Hospitalization   [ Time Frame: from start of weaning to discharge from hospital, on average 1-2 weeks ]

5.  Secondary:   Inpatient Mortality   [ Time Frame: 28 days ]

6.  Secondary:   Sedation Requirements   [ Time Frame: during weaning, on average 1-2 days ]

7.  Secondary:   Number of Spontaneous Breathing Trials Prior to Extubation   [ Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days ]

8.  Secondary:   Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)   [ Time Frame: Duration of weaning (median 2 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was terminated early due to slow recruitment. It did not reach the target N of 220.


  More Information
  Hide More Information

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: Allan Walkey, MD, MSc
Organization: Boston University School of Medicine
phone: 617-638-4860
e-mail: alwalkey@bu.edu



Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00606554     History of Changes
Other Study ID Numbers: H-26906
First Submitted: January 3, 2008
First Posted: February 4, 2008
Results First Submitted: February 7, 2011
Results First Posted: August 17, 2011
Last Update Posted: December 11, 2017