Clinical trial NCT00322010: Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit
Official title: A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mechanically Ventilated Patients
Keywords: mechanical ventilation
physical therapy
occupational therapy
mobilization
clinical protocols
ICU acquired weakness
critical illness myopathy
muscle atrophy
intensive care unit
randomized controlled trial
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2006-05-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study all ICU patients with an independent baseline functional status, who experience a critical illness requiring intubation and mechanical ventilation, evaluating the role of protocol-directed, early physical and occupational therapy on the incidence of critical illness associated functional debilitation. Our goal is to hasten the recovery of independent physical functioning as well as to reduce ICU delirium in the group of patients who begin this intervention from the earliest hours of ventilator dependence.


Eligibility criteria: Inclusion Criteria

1. Patients intubated and mechanical ventilated for \< 72 hours
2. Age \> 18 years
3. Baseline independent functional status as assessed by a Barthel Index score \> 70 collected from a proxy reflecting baseline health 2 weeks prior to critical illness

Exclusion Criteria

1. Rapidly evolving neurological/neuromuscular disease
2. Cardiac arrest
3. Irreversible conditions with six month mortality estimated at \> 50%
4. Elevated intracranial pressure
5. Multiple absent limbs (precluding complete musculoskeletal examination)
6. Enrollment in another trial

Primary outcomes:
measure: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation
timeFrame: Hospital Discharge
Secondary outcomes:
measure: Number of hospital days with delirium
timeFrame: Hospital discharge
measure: Number of days alive and breathing without assistance (ventilator-free days)
timeFrame: during 28-day study period
measure: length of stay
timeFrame: ICU and Hospital discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: John P Kress, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.