Using Ultrasound to Study Respiratory Muscle Function in Critically Ill Patients

Completed

Conditions studied: Injury of Diaphragm, Mechanical Ventilation Complication, Critical Illness

In brief

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.

Key facts

Study ID

NCT03139695

Run by

Wake Forest University Health Sciences

People needed

75

Starts

2012-11-01

Expected to finish

2016-07-01

Last updated by the study team

2017-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Wake Forest Univesity Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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