Weaning From Prolonged Mechanical Ventilation

Acute Mechanical Ventilatory Failure Clinical Trial

Official title:

Weaning From Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541462
• Other study ID #: AXJ001
• Secondary ID: 5R01NR008782
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: February 23, 2012
• Start date: October 2000
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: RML Specialty Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Mechanical Ventilatory Failure
• Hypoventilation

Intervention

Other:
• Weaning
Decrease assistance provided by the ventilator

Locations

Country	Name	City	State
United States	RML Specialty Hospital	Hinsdale	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
RML Specialty Hospital	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning duration		From the first day of randomization to the day the patient was successfully weaned up to 5 days	No
Secondary	mortality		6 and 12 month	No