Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT00896220

Conditions

Critically Ill

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Advances in critical care medicine have dramatically improved the survival of critically ill patients requiring prolonged mechanical ventilation. However, there are no systematic follow-up, rehabilitation, or psychoeducational interventions for these vulnerable patients or their family caregivers who contribute to survivor recovery and rehabilitation. Major barriers to developing these programs for survivors of prolonged mechanical ventilation and their caregivers include the following:

1. There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation.
2. There is inadequate information about the needs of survivors of prolonged mechanical ventilation and their family caregivers across the trajectory of illness (i.e., from the ICU to the community).
3. There is a poor understanding of the development of ICU-acquired muscle injury.

Towards RECOVER is the very first study to identify survivors of prolonged mechanical ventilation who are at-risk for poor functional outcomes, to identify elements of the care-giving situation that put caregivers at risk for poor quality of life and mental health, to catalogue the rehabilitative needs of patients and family caregivers across the illness trajectory, and to evaluate the mechanism of critical illness associated muscle injury.

The RECOVER Program consists of Four Phases:

  • Phase I: Towards RECOVER
  • Phase II: RECOVER development and pilot testing
  • Phase III: RECOVER randomized controlled trial
  • Phase IV: Long-term implementation of RECOVER

Conditions

Critically Ill

Study ID

NCT00896220

Start date

Apr, 2006

Status verified date

May, 2009

Completion date

Oct, 2012

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Older than 16 years of age.
  • Mechanically ventilated for a minimum of one week in study ICU.

Exclusion Criteria:

  • Catastrophic Neurological Injury in the opinion of the attending intensivist (ex. Grade V SAH or massive CVA).
  • Pre-existing Formal diagnosis of neuromuscular disease.
  • Non-ambulatory prior to hospital or ICU admission.
  • Anticipated death or withdrawal of life sustaining treatment within 48 hours.
  • History of psychiatric illness with documented admission.
  • Patient is not fluent in English.
  • Documented discussion re: imminent withdrawal of life sustaining treatment.
  • Lives greater than 300 km from referral centre.
  • Patient no living at a fixed address.
  • Physician refusal.
  • Patient of SDM (substitute decision maker) refuses consent.
  • No next of kin of SDM available (if patient unable to provide consent).

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

ICU Survivors and Their Family Caregiver

ICU Survivors who required one week or more of mechanical ventilation during their critical illness and their primary family caregiver

Primary outcome measure

  • Functional Independence Measure (FIM) - ICU Survivor [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ]
  • Six Minute Walking Test (6MWT) - ICU Survivor [ Time Frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Neill Adhikari, MD

neil.adhikari@sunnybrook.ca

Principal Investigator:

Neill Adhikari, MD FRCPC MSc

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Principal Investigator:

Jan Friedrich, PhD MD FRCPC

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Sangeeta Mehta, MD

geeta.mehta@utoronto.ca

Principal Investigator:

Sangeeta Mehta, MD FRCPC

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Principal Investigator:

Niall Ferguson, MD FRCPC MSc

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Principal Investigator:

Margaret S. Herridge, MSc MD FRCPC MPH

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 9, 2009

Last verified

May, 2009

Keywords

  • chronic critical illness
  • mechanical ventilation
  • outcomes
  • weakness
  • quality of life
  • Critically Ill patients and their family caregiver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2009-10-09.