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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: Usual Care; Other: Early ICU rehabilitation strategies

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; Usual hospital rehabilitative services	Other: Usual Care; All typically applied hospital rehabilitative services applied in the usual fashion; Other Names: Usual Hospital Rehabilitative Services
Experimental: Early ICU Rehabilitation Strategy; Early ICU physical therapy will be applied in this arm	Other: Early ICU rehabilitation strategies; Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II; 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?

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.

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Peter E. Morris, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: ICU; Physical Therapy; Critical Illness; Mechanical Ventilation; Intensive Care; Strength; Critical Care; Functional Status; Acute Respiratory Failure; Short Physical Performance Battery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: IRB00000240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No