Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure

Study Overview
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Brief Summary
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This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.

Official Title
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Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Other: Early ICU rehabilitation strategies
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Mechanically ventilated via an endotracheal tube or mask Exclusion Criteria: Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions) Cognitive impairment prior to acute ICU illness (non-verbal) Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks) Acute stroke Body mass index (BMI) >45 Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre) Hip fracture, unstable cervical spine or pathological fracture Mech vent >48 hours prior to transfer from an outside facility Current hospitalization or transferring hospital stay >72 hours CPR on admission, DNR on admission Hospitalization within 30 days prior to admission Cancer therapy within last 6 months Re-admission to ICU within current hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care<br>Usual hospital rehabilitative services | Other: Usual Care<br>* All typically applied hospital rehabilitative services applied in the usual fashion<br>* Other names: Usual Hospital Rehabilitative Services;|
| Experimental: Early ICU Rehabilitation Strategy<br>Early ICU physical therapy will be applied in this arm | Other: Early ICU rehabilitation strategies<br>* Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II<br>* Other names: Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay, days | Hospital stay measured in days. | The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, Critical Care, Intensive Care, Critical Illness, Acute Respiratory Failure, Mechanical Ventilation, Physical Therapy, Strength, Functional Status, Short Physical Performance Battery