Status:
COMPLETED
eStimCycle: Early Rehabilitation in Critical Care
Lead Sponsor:
Associate Professor Sue Berney PhD, BPT
Conditions:
Intensive Care Unit Acquired Weakness (ICUAW)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Project Summary: Patients who have a length of stay four or more days in ICU and requiring mechanical ventilation assistance to breathe for more than 48 hours will be invited to participate. Participa...
Eligibility Criteria
Inclusion
- ≥18 years,
- expected mechanical ventilation or ECMO \>48 h with evidence of systemic inflammation as defined by American College of Chest Physicians (ACCP) Consensus Conference Criteria and
- predicted ICU length of stay ≥4 days.
Exclusion
- Known primary systemic neuromuscular disease or intracranial process on ICU admission
- Lower limb amputation/s
- Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
- Assessed by medical staff as not-expected to survive ICU
- Pregnancy
- BMI \> 40
- Presence of external fixator or superficial metal in lower limb
- Open wounds or skin abrasions at electrode application points
- Presence of cardiac or diaphragmatic pacemaker or implanted defibrillator with no underlying rhythm, as confirmed by the treating physician
- Transferred from another ICU after \> 2 days of mechanical ventilation
- Platelets \< 40 000 and INR \> 1.6 (for muscle biopsy)
- Lower limb malignancy
- Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions.
- Non-English speaking background restricting the individuals ability to accurately and consistently follow instructions.
- Exclusion criteria for the 6 and 12 month cognitive testing follow-up portion of the study:
- Cognitive impairment (IQCODE \>3.3) done by proxy after informed consent obtained
- No fixed home address
- Score \>= 10 on Alcohol use disorders and identification test (AUDIT)
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT02214823
Start Date
July 1 2012
End Date
October 1 2018
Last Update
October 11 2018
Active Locations (4)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
2
Duke University
Durham, North Carolina, United States, 27708
3
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4006
4
Austin Hospital
Melbourne, Victoria, Australia, 3084