Weaning From Prolonged Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Mechanical Ventilatory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pressure support

Patients randomized to the pressure support arm will wean using pressure support ventilation. The level of pressure support will be decreased by 2 cm H2O every 6 hours. The maximum decrement in pressure support permitted in one day will be 6 cm H2O.

Group Type ACTIVE_COMPARATOR

Weaning

Intervention Type OTHER

Decrease assistance provided by the ventilator

Spontaneous Breathing

Patients randomized to spontaneous breathing arm will be disconnected from the ventilator and allowed to breathe spontaneously through the tracheostomy. Duration of the trial will be increased sequentially as tolerated.

Group Type ACTIVE_COMPARATOR

Weaning

Intervention Type OTHER

Decrease assistance provided by the ventilator

Interventions

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Weaning

Decrease assistance provided by the ventilator

Intervention Type OTHER

Other Intervention Names

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Pressure support Spontaneous breathing

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No