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

February 16, 2012
February 23, 2012
October 2000
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01541462 on ClinicalTrials.gov Archive Site
mortality [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Weaning From Prolonged Mechanical Ventilation
Weaning From Prolonged Mechanical Ventilation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Acute Mechanical Ventilatory Failure
Other: Weaning
Decrease assistance provided by the ventilator
Other Names:
  • Pressure support
  • Spontaneous breathing
  • 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.
    Intervention: Other: Weaning
  • 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.
    Intervention: Other: Weaning
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
October 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01541462
AXJ001, 5R01NR008782
No
Amal Jubran, RML Specialty Hospital
RML Specialty Hospital
National Institute of Nursing Research (NINR)
Principal Investigator: Amal Jubran, MD RML Specialty Hospital
RML Specialty Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP