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Weaning From Prolonged Mechanical Ventilation

Weaning From Prolonged Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01541462
Enrollment
500
Registered
2012-03-01
Start date
2000-10-31
Completion date
2011-10-31
Last updated
2012-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Mechanical Ventilatory Failure

Keywords

mechanical ventilation, weaning, pressure support, spontaneous breathing, Long-term acute care facility, mortality

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.

Interventions

OTHERWeaning

Decrease assistance provided by the ventilator

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
RML Specialty Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Weaning durationFrom the first day of randomization to the day the patient was successfully weaned up to 5 days

Secondary

MeasureTime frame
mortality6 and 12 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026