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Acute Respiratory FailureMUSCULARNCT02014285

Muscle Ultrasound Signifies Condition Upgrade Leading Approach to Recovery

An observational study of Acute Respiratory Failure and Critical Illness, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Failure, Critical Illness
What is being tested?
Muscle Ultrasound and Muscle Sample
Type of treatment
Surgery or procedure
How many people
1 participants
Where
1 siteUnited States
Study dates
Nov 2012to 3 May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Upon Principle Investigator discretion, patient not suitable for study
  • Moribund
  • Other Research Study without co-enrollment permissions
  • Pregnancy
  • Primary neuropathies
  • Amputees
Show all 23Show fewer
  • Inability to walk without assistance prior to diagnosis (use of cane or walker not exclusion)
  • 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
  • Re-admission to ICU within current admission
  • Cancer therapy within the last 12 months
  • Full dose anticoagulation therapy
  • Known platelet count <100,000
  • Known INR >1.5
  • Known aPTT >1.5 upper limit of normal
  • Patient on antiplatelet therapy (daily aspirin therapy is acceptable)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the detailed description

Acute respiratory failure (ARF) is an extremely variable and heterogeneous syndrome that can be defined as an acute cardiopulmonary dysfunction requiring emergent artificial ventilation support. For patients with ARF, the mortality rate is higher than the general ICU mortality, with estimates ranging from 15-40% depending on the subgroups evaluated. In the largest, most recent report on ARF, the in-ICU mortality was 31% and the overall in-hospital mortality rate was 37%. Muscle weakness is an independent risk factor for mortality from ARF and contributes to long-term reductions in physical function in survivors. Muscle ultrasounds are non-invasive, quick and reproducible. They provide the opportunity of ICU staff to create a patient-specific exercise prescription based on both functional assessments and importantly the degree of muscle architecture abnormality detected by ultrasound. Serial examination of muscle ultrasound images obtained in mechanically ventilated acute respiratory failure patients will allow for better understanding of the time course of specific muscles' architectural abnormalities and the resolution of such abnormalities within hospital survivors. 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. Muscle sampling used in conjunction with ultrasound in patients with ARF will allow for further characterization of the extent of and mechanisms underlying ARF induced muscle dysfunction in these patients. Furthermore, ultrasound guided muscle sampling allows this procedure to be done in a more efficient and effective manner. Study participants will consist of 30 patients with ARF admitted to the Intensive Care Units of Wake Forest University Baptist Medical Center. Muscle ultrasounds will occur at study enrollment and weekly thereafter, and will also include one imaging session as close to hospital discharge as possible. Muscle sampling will occur within 5 days of consent and approximately 2 months later. Handgrip strength, dynamometer, and physical performance tests will also be administered at ICU \& hospital discharge and at 2 months post enrollment. The primary outcome will be to investigate the possibility of a relationship between the ultrasound data, muscle sample data, and functional measurements (length of stay, grip strength, SPPB, dynamometer, MRC, simultaneously accounting for severity of illness [APACHE III]).

Being tested
Muscle Ultrasound and Muscle Sample
Keywords
Acute Respiratory Failure, Critical Illness, Mechanical Ventilation, Muscle Architecture, Muscle Ultrasound
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Muscle Ultrasound and Muscle SampleProcedure or surgery

    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.

Study groups in NCT02014285
Study groupRoleWhat they receive
Muscle Ultrasound/Sample30 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.
Receives: Procedure: Muscle Ultrasound and Muscle Sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2013 (estimated)
  2. Study startNov 2012
  3. Primary completion3 May 2017
  4. Study completion3 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02014285
Sponsor's protocol ID
00022113
Acronym
MUSCULAR
Status last verified
Aug 2017
First submitted
27 Nov 2013
Last updated
8 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Failure and Critical Illness, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days of Hospitalization (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.

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