Mechanical Ventilation Clinical Trial
Official title:
Computer Driven Management of Weaning Following Prolonged Mechanical Ventilation: a Pilot Study
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | November 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maintenance of spontaneous breathing | 7 days |
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