search
Back to results

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

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early ICU rehabilitation strategies
Usual Care
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring ICU, Critical Care, Intensive Care, Critical Illness, Acute Respiratory Failure, Mechanical Ventilation, Physical Therapy, Strength, Functional Status, Short Physical Performance Battery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual Care

Early ICU Rehabilitation Strategy

Arm Description

Usual hospital rehabilitative services

Early ICU physical therapy will be applied in this arm

Outcomes

Primary Outcome Measures

Hospital length of stay, days
Hospital stay measured in days.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2012
Last Updated
August 13, 2018
Sponsor
Wake Forest University
search

1. Study Identification

Unique Protocol Identification Number
NCT01707303
Brief Title
Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
ICU, Critical Care, Intensive Care, Critical Illness, Acute Respiratory Failure, Mechanical Ventilation, Physical Therapy, Strength, Functional Status, Short Physical Performance Battery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual hospital rehabilitative services
Arm Title
Early ICU Rehabilitation Strategy
Arm Type
Experimental
Arm Description
Early ICU physical therapy will be applied in this arm
Intervention Type
Other
Intervention Name(s)
Early ICU rehabilitation strategies
Other Intervention Name(s)
Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.
Intervention Description
Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Usual Hospital Rehabilitative Services
Intervention Description
All typically applied hospital rehabilitative services applied in the usual fashion
Primary Outcome Measure Information:
Title
Hospital length of stay, days
Description
Hospital stay measured in days.
Time Frame
The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E. Morris, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs