Using Ultrasound to Study Respiratory Muscle Function in Critically Ill Patients

NCT03139695 | Completed

• 1 other identifier: IRB00022412
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation can be life saving strategy for patients with respiratory failure due to a variety of reasons. Once the underlying illness has resolved, intensive care doctors have to take a decision on when the patient is safe to get off the ventilator or be extubated. They use clinical assessment of the patient's ability to breathe spontaneously and make use of some breathing parameters to make the judgment. Most of the time, a patient can come off the ventilator and do well, but sometimes muscle weakness from sickness can affect the patient's ability to breathe adequately once ventilator support is discontinued. If that occurs, the patient may have to be put back on the ventilator and the physician will suggest some changes to help muscles get stronger. A simple, non-invasive test that can assess respiratory muscle state before taking patients off the ventilator to see if their muscles look healthy can help distinguish which patients may not be ready to be extubated. There are currently several tests available to assess muscle strength, in particular muscles that help in breathing like the intercostal muscles and diaphragm. The study will test the use of Ultrasonography (Ultrasound) as a non-invasive test to assess the muscles of respiration. This test will also help the investigators test physical therapies and interventions of mechanical ventilation that can help patients strengthen the muscles while waiting for extubation.

Conditions

Injury of Diaphragm; Mechanical Ventilation Complication; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of thickening fraction of diaphragm muscle

  Muscle thickness will be measured at end inspiration and end expiration images of diaphragm to ascertain the thickening fraction of the diaphragm. Progression of muscle thickening fraction during mechanical ventilation will be assessed.

  7 days

Secondary Outcomes (8)

• Change from Baseline of Echodensity of diaphragm muscle

  7 days

• Change from Baseline of thickness of intercostal muscle

  7 days

• Change from Baseline of Echodensity of intercostal muscle

  7 days

• Duration of mechanical ventilation

  Through study completion, expected less than 6 months

• Success / failure at spontaneous breathing trials

  Through study completion, expected less than 6 months

Study Arms (1)

Critically ill patients

High resolution ultrasound of the diaphragm and intercostal muscle

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

High resolution Ultrasound of the Diaphragm and Intercostal muscles

Critically ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years of age) in intensive care unit

You may qualify if:

• Patients will be included if first ultrasound measurement can be performed within 48 hours of ICU admission and informed consent can be obtained from patient or designated health care representative.
• Adult patients (≥ 18 years of age) in any intensive care unit.
• Patients who are expected to have the need for prolonged mechanical ventilation (treating physician's assessments that patient will likely need mechanical ventilation for \>48 hours; 2 days) and have been on mechanical ventilation for \<48 hours at the time of enrollment.

You may not qualify if:

• Patients in any ICU who is expected to be on mechanical ventilation for \<48 hours based on treating physicians judgment.
• Patients that were on MV for more than 48 hours prior to transfer to the ICU.
• Patients who are expected to be extubated, transferred out of the ICU or discharged from the intensive care unit in the next 48 hours based on treating physicians judgment.
• Patients who are transitioning to palliative care or expected to die in the next 48 hours based on treating physicians judgment.
• Any patient where access to chest to study intercostal muscle and diaphragm is limited due to skin /subcutaneous lesions.
• Patients with a history of or current chest tubes, chest trauma or anterior rib fractures.
• Patients with a history of prior MV \>48 hours or prior history of tracheostomy.
• Patients with a history of chest or abdominal surgery.
• Patients that have a tracheotomy or require non-standard modes of ventilation including airway pressure release ventilation or high frequency oscillatory ventilation.
• Patients with physician orders for positioning of the patient is different from head of the bed at 30 degree. E.g. patients with recent lumbar spinal surgery are laid flat to reduce spinal fluid pressure in lumbar area.
• Patients with a known allergy to ultrasound gel
• Pregnant women

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (8)

• Sarwal A, Liu A, Cartwright MS, Dhar S, Morris PE. Sonography for Assessing Dynamic Diaphragm Dysfunction in Acute Respiratory Distress. J Ultrasound Med. 2015 Sep;34(9):1701-6. doi: 10.7863/ultra.15.14.10047. Epub 2015 Aug 17. No abstract available.

  PMID: 26283757 BACKGROUND

• Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.

  PMID: 26211979 BACKGROUND

• Sarwal A, Parry SM, Berry MJ, Hsu FC, Lewis MT, Justus NW, Morris PE, Denehy L, Berney S, Dhar S, Cartwright MS. Interobserver Reliability of Quantitative Muscle Sonographic Analysis in the Critically Ill Population. J Ultrasound Med. 2015 Jul;34(7):1191-200. doi: 10.7863/ultra.34.7.1191.

  PMID: 26112621 BACKGROUND

• Sarwal A, Cartwright MS, Walker FO, Mitchell E, Buj-Bello A, Beggs AH, Childers MK. Ultrasound assessment of the diaphragm: Preliminary study of a canine model of X-linked myotubular myopathy. Muscle Nerve. 2014 Oct;50(4):607-9. doi: 10.1002/mus.24294. Epub 2014 Aug 30.

  PMID: 24861988 BACKGROUND

• Sarwal A, Cartwright MS, Mitchell E, Williams K, Walker FO, Childers MK. Guiding intramuscular diaphragm injections using real-time ultrasound and electromyography. Muscle Nerve. 2015 Feb;51(2):287-9. doi: 10.1002/mus.24493.

  PMID: 25354257 BACKGROUND

• Sarwal A, Walker FO, Cartwright MS. Neuromuscular ultrasound for evaluation of the diaphragm. Muscle Nerve. 2013 Mar;47(3):319-29. doi: 10.1002/mus.23671. Epub 2013 Feb 4.

  PMID: 23382111 BACKGROUND

• Cartwright MS, Kwayisi G, Griffin LP, Sarwal A, Walker FO, Harris JM, Berry MJ, Chahal PS, Morris PE. Quantitative neuromuscular ultrasound in the intensive care unit. Muscle Nerve. 2013 Feb;47(2):255-9. doi: 10.1002/mus.23525. Epub 2012 Oct 5.

  PMID: 23041986 BACKGROUND

• Morris PE, Berry MJ, Files DC, Thompson JC, Hauser J, Flores L, Dhar S, Chmelo E, Lovato J, Case LD, Bakhru RN, Sarwal A, Parry SM, Campbell P, Mote A, Winkelman C, Hite RD, Nicklas B, Chatterjee A, Young MP. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2694-702. doi: 10.1001/jama.2016.7201.

  PMID: 27367766 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Aarti Sarwal, MD

  Wake Forest UBMC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 4, 2017
• Study Start: November 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)