NCT01541462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

9.7 years

First QC Date

February 16, 2012

Last Update Submit

February 23, 2012

Conditions

Acute Mechanical Ventilatory Failure

Keywords

mechanical ventilationweaningpressure supportspontaneous breathingLong-term acute care facilitymortality

Outcome Measures

Primary Outcomes (1)

  • Weaning duration

    From the first day of randomization to the day the patient was successfully weaned up to 5 days

Secondary Outcomes (1)

  • mortality

    6 and 12 month

Study Arms (2)

Pressure support

ACTIVE COMPARATOR

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

Spontaneous Breathing

ACTIVE COMPARATOR

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

Interventions

WeaningOTHER

Decrease assistance provided by the ventilator

Also known as: Pressure support, Spontaneous breathing
Pressure supportSpontaneous Breathing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanical Ventilation for at least 21 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

Location

Related Publications (1)

  • 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.

    PMID: 23340588DERIVED

MeSH Terms

Interventions

Weaning

Intervention Hierarchy (Ancestors)

Infant Nutritional Physiological PhenomenaChild Nutritional Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Amal Jubran, MD

    RML Specialty Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

February 16, 2012

First Posted

March 1, 2012

Study Start

October 1, 2000

Primary Completion

June 1, 2010

Study Completion

October 1, 2011

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations

US(1)