Weaning From Prolonged Mechanical Ventilation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amal Jubran, RML Specialty Hospital
ClinicalTrials.gov Identifier:
NCT01541462
First received: February 16, 2012
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Acute Mechanical Ventilatory Failure
Other: Weaning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Weaning From Prolonged Mechanical Ventilation

Further study details as provided by RML Specialty Hospital:

Primary Outcome Measures:
  • Weaning duration [ Time Frame: From the first day of randomization to the day the patient was successfully weaned up to 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: October 2000
Study Completion Date: October 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Weaning
Decrease assistance provided by the ventilator
Other Names:
  • Pressure support
  • Spontaneous breathing
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.
Other: Weaning
Decrease assistance provided by the ventilator
Other Names:
  • Pressure support
  • Spontaneous breathing

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541462

Locations
United States, Illinois
RML Specialty Hospital
Hinsdale, Illinois, United States, 60521
Sponsors and Collaborators
RML Specialty Hospital
Investigators
Principal Investigator: Amal Jubran, MD RML Specialty Hospital
  More Information

No publications provided by RML Specialty Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amal Jubran, Attending Physician, RML Specialty Hospital
ClinicalTrials.gov Identifier: NCT01541462     History of Changes
Other Study ID Numbers: AXJ001, 5R01NR008782
Study First Received: February 16, 2012
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by RML Specialty Hospital:
mechanical ventilation
weaning
pressure support
spontaneous breathing
Long-term acute care facility
mortality

Additional relevant MeSH terms:
Hypoventilation
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014