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

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Other: Usual Care; Other: Early ICU rehabilitation strategies

• Registration Number: NCT01707303
• Lead Sponsor: Wake Forest University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Usual hospital rehabilitative services
Early ICU Rehabilitation Strategy	Early ICU rehabilitation strategies	Early ICU physical therapy will be applied in this arm

Primary Outcome Measures

Name	Time	Method
Hospital length of stay, days	The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.	Hospital stay measured in days.

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States