Computer Driven Management of Weaning Following Prolonged Mechanical Ventilation

NCT00502489 | Unknown

• 1 other identifier: 4242
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mechanical Ventilation; Weaning; Prolonged Ventilation

Keywords

prolonged mechanical ventilation; weaning;rehabilitation

Outcome Measures

Primary Outcomes (1)

• Maintenance of spontaneous breathing

  7 days

Interventions

Closed-loop sytem for5 weaning from mechanical ventilation PROCEDURE

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Officials

• Gregory Papirov, MD

  Rabin Medical Center, Beilinson Hospital, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Papirov, MD

CONTACT

+972-3-9376525

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2007
• First Posted: July 17, 2007
• Study Start: October 1, 2007
• Study Completion: November 1, 2008
• Last Updated: July 17, 2007

Record last verified: 2007-05