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Clinical Trials/NCT01541462
NCT01541462
Completed
N/A

Weaning From Prolonged Mechanical Ventilation

RML Specialty Hospital1 site in 1 country500 target enrollmentOctober 2000

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Mechanical Ventilatory Failure
Sponsor
RML Specialty Hospital
Enrollment
500
Locations
1
Primary Endpoint
Weaning duration
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

Patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC facilities, research on the fastest method for disconnecting the patient from the respirator is lacking. In addition, little information is available regarding the long-term survival and quality of life after a prolonged course of artificial ventilation. The purpose of this study is to determine the fastest method for disconnecting the patient from the respirator at a LTAC facility and its effect on long-term survival and quality of life.

Detailed Description

Patients requiring prolonged mechanical ventilation (defined as more than 21 days) account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning from mechanical ventilation, so called long-term acute care (LTAC) facilities. Despite the proliferation of LTAC facilities, research on methods for expediting weaning is lacking. In addition, little information is available regarding long-term survival and patient's perception of quality of life after a prolonged course of mechanical ventilation. In patients receiving mechanical ventilation in an ICU, randomized trials have revealed that ventilator duration was significantly influenced by weaning methods. The two most common weaning methods are pressure support and spontaneous breathing trials. Unlike the ICU, the relative efficacy of these two techniques in weaning patients requiring prolonged ventilation at a LTAC facility is largely unknown. The aim of this proposal is to determine whether the length of time required for weaning from prolonged ventilation differs with pressure support versus spontaneous breathing trials. The second aim is to determine the long-term impact of prolonged ventilation on survival, functional status and quality of life.

Registry
clinicaltrials.gov
Start Date
October 2000
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amal Jubran

Attending Physician

RML Specialty Hospital

Eligibility Criteria

Inclusion Criteria

  • Mechanical Ventilation for at least 21 days

Exclusion Criteria

  • Hypoxemia (oxygen saturation \< 90% with fractional inspired O2 concentration \> 0.40, and positive end-expiratory pressure \> 5 cm H2O
  • Hemodynamic instability (requiring intravenous vasoactive agents, such as dopamine \> 5 mg/kg/min)
  • Profound neurological deficits (large stroke)
  • Documented bilateral phrenic nerve injury
  • Previous admission to RML Hospital
  • Life expectancy less than 3 months

Outcomes

Primary Outcomes

Weaning duration

Time Frame: From the first day of randomization to the day the patient was successfully weaned up to 5 days

Secondary Outcomes

  • mortality(6 and 12 month)

Study Sites (1)

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