Clinical trial NCT01541462: Weaning From Prolonged Mechanical Ventilation
Official title: Weaning From Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Mechanical Ventilatory Failure
Keywords: mechanical ventilation
weaning
pressure support
spontaneous breathing
Long-term acute care facility
mortality
Lead sponsor: RML Specialty Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weaning duration
timeFrame: From the first day of randomization to the day the patient was successfully weaned up to 5 days
Secondary outcomes:
measure: mortality
timeFrame: 6 and 12 month
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: RML Specialty Hospital
state: Illinois
Study officials:
affiliation: RML Specialty Hospital
name: Amal Jubran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jubran A, Grant BJ, Duffner LA, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ. Effect of pressure support vs unassisted breathing through a tracheostomy collar on weaning duration in patients requiring prolonged mechanical ventilation: a randomized trial. JAMA. 2013 Feb 20;309(7):671-7. doi: 10.1001/jama.2013.159.