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Weaning From Prolonged Mechanical Ventilation

Primary Purpose

Acute Mechanical Ventilatory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weaning
Sponsored by
RML Specialty Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Mechanical Ventilatory Failure focused on measuring mechanical ventilation, weaning, pressure support, spontaneous breathing, Long-term acute care facility, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RML Specialty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pressure support

Spontaneous Breathing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weaning duration

Secondary Outcome Measures

mortality

Full Information

First Posted
February 16, 2012
Last Updated
February 23, 2012
Sponsor
RML Specialty Hospital
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01541462
Brief Title
Weaning From Prolonged Mechanical Ventilation
Official Title
Weaning From Prolonged Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RML Specialty Hospital
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mechanical Ventilatory Failure
Keywords
mechanical ventilation, weaning, pressure support, spontaneous breathing, Long-term acute care facility, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure support
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Spontaneous Breathing
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Weaning
Other Intervention Name(s)
Pressure support, Spontaneous breathing
Intervention Description
Decrease assistance provided by the ventilator
Primary Outcome Measure Information:
Title
Weaning duration
Time Frame
From the first day of randomization to the day the patient was successfully weaned up to 5 days
Secondary Outcome Measure Information:
Title
mortality
Time Frame
6 and 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Jubran, MD
Organizational Affiliation
RML Specialty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RML Specialty Hospital
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23340588
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.
Results Reference
derived

Learn more about this trial

Weaning From Prolonged Mechanical Ventilation

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