Muscle Ultrasound Signifies Condition Upgrade Leading Approach to Recovery

NCT02014285 | Completed DMC

• 1 other identifier: 00022113
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Examination of serial muscle ultrasounds and muscle sampling within the population of ICU patients who require mechanical ventilation for acute respiratory failure, will lead to the ability of investigators to link specific baseline comorbidities, drugs, or fluid administrations, to the onset and duration of architectural changes within muscle and correlate ultimately with muscle function. With this study, we will be better able to understand the relationships between the pattern of resolution of the muscle architectural abnormalities within the context of multiple other clinical abnormalities and therapies present and rendered to ICU patients.

Conditions

Acute Respiratory Failure; Critical Illness

Keywords

Acute Respiratory Failure; Critical Illness; Mechanical Ventilation; Muscle Architecture; Muscle Ultrasound

Outcome Measures

Primary Outcomes (1)

• Days of Hospitalization

  The ultrasound data analysis may allow for a correlation to be drawn between a pattern of ultrasound changes and length of stay.

  2 months

Study Arms (1)

Muscle Ultrasound/Sample

30 subjects enrolled from Wake Forest Baptist Health Intensive Care Units. Each study subject will undergo an ultrasound to examine the size and echogenicity of their muscles and a muscle biopsy from the rectus femoris. The muscles studied will include the biceps brachii, wrist extensors, quadriceps, and tibialis anterior.

Procedure: Muscle Ultrasound and Muscle Sample

Interventions

Muscle Ultrasound and Muscle Sample PROCEDURE

The muscles to undergo ultrasound will include the biceps brachii, wrist extensors, quadriceps, and tibialis anterior. A muscle sample will be taken from the rectus femoris.

Muscle Ultrasound/Sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will consist of 30 patients with Acute Respiratory Failure admitted to the Intensive Care Units of Wake Forest Baptist Health.

You may qualify if:

• Age \> 18 years
• Mechanically ventilated via an endotracheal tube or mask
• New diagnosis of Acute Lung Injury or Sepsis

You may not qualify if:

• Upon Principle Investigator discretion, patient not suitable for study
• Moribund
• Other Research Study without co-enrollment permissions
• Pregnancy
• Primary neuropathies
• Amputees
• Preadmission immunocompromised state (HIV, \>20mg prednisone/day, other immunosuppressive therapy)
• BMI \>45 (difficulty obtaining biopsy)
• Underlying neuromuscular disease
• Acute stroke
• Hip fracture, unstable C spine, or pathological fracture
• Current hospitalization or transferring hospital stay \>80 hours
• CPR previous to consent without signs of full neurologic recovery
• Previous hospitalization within past 30 days
• Cognitive impairment prior to ICU illness

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Muscle tissue and serum/plasm

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clark Files, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Peter E Morris, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 18, 2013
• Study Start: November 1, 2012
• Primary Completion: May 3, 2017
• Study Completion: May 3, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)