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Completed

NCT Number: NCT01541462

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weaning

Other

Decrease assistance provided by the ventilator

Other names: Pressure support, Spontaneous breathing

Primary outcomes

  1. Weaning duration

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

Secondary outcomes

  1. mortality

    Time frame: 6 and 12 month

Sponsors and collaborators

Lead sponsor

RML Specialty Hospital

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2000
Primary completion
2010
Study completion
2011
First posted
Mar 1, 2012
Registry last updated
Mar 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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