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

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707303
• Other study ID #: IRB00000240
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Other:
• Early ICU rehabilitation strategies
Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II
• Usual Care
All typically applied hospital rehabilitative services applied in the usual fashion

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.