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Computer Driven Management of Weaning Following Prolonged Mechanical Ventilation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502489
First Posted: July 17, 2007
Last Update Posted: July 17, 2007
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:
Rabin Medical Center
  Purpose

After an episode of acute respiratory failure requiring mechanical ventilation, weaning the patient from the ventilator may be difficult. Discontinuation of ventilation is estimated to take up to 40% of the total duration of ventilatory support. Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial. Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality.

Identifying weaning readiness early and reliably is therefore crucial. Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation, most notably the weaning period.

Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection. No data on the use of such a computer driven system (CDS) in elderly patients requiring prolonged ventilation in weaning centers (non ICU) have been reported.

The Objective of the present study is to evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol. The CDS continuously adapts pressure support, gradually decreasing ventilator assistance according to patient ability, and thus indicates weaning readiness. Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation.


Condition Intervention
Mechanical Ventilation Weaning Prolonged Ventilation Procedure: Closed-loop sytem for5 weaning from mechanical ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer Driven Management of Weaning Following Prolonged Mechanical Ventilation: a Pilot Study

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Maintenance of spontaneous breathing [ Time Frame: 7 days ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: November 2008
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pressure support ventilation (PSV) for at least 48 h,
  • Plateau pressure less than 30 cmH2O,
  • PEEP < 6 cmH2O, PaO2/FIO2 ratio > 150 or SaO2 > 94% with FIO2 < than 0.5,
  • pCO2 <55 mm Hg for normal patients and < 65 m Hg for patients with COPD,
  • No requirement for inotropic support,
  • Body temperature > 36.50C and < 38.50 C,
  • Stable neurological status with Glasgow Coma Score (GCS) > 6, HgB > 8 mg %,
  • Systolic blood pressure >90 mg Hg,
  • Mean arterial pressure >65 mg Hg,
  • Absence of sedative medications and availability of CDS at the time of patient admission or switching to pressure support ventilation (PSV).

Exclusion Criteria:

  • Patients younger than 60 or older than 85 years of age,
  • Patients on chronic ventilatory assistance at home; and
  • Patients with decision to limit life-sustaining treatments
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00502489


Contacts
Contact: Gregory Papirov, MD +972-3-9376525

Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Gregory Papirov, MD Rabin Medical Center, Beilinson Hospital, Israel
  More Information

ClinicalTrials.gov Identifier: NCT00502489     History of Changes
Other Study ID Numbers: 4242
First Submitted: July 15, 2007
First Posted: July 17, 2007
Last Update Posted: July 17, 2007
Last Verified: May 2007

Keywords provided by Rabin Medical Center:
prolonged mechanical ventilation; weaning;rehabilitation