Weaning From Prolonged Mechanical Ventilation

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2010

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

  • Other: Weaning
    • Decrease assistance provided by the ventilator

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • mortality
    • Time Frame: 6 and 12 month

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RML Specialty Hospital
  • Collaborator
    • National Institute of Nursing Research (NINR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amal Jubran, Attending Physician – RML Specialty Hospital
  • Overall Official(s)
    • Amal Jubran, MD, Principal Investigator, RML Specialty Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.