Active, not recruitingNCT05875883ClinicalTrials.gov record

Phrenic Identification in the ICU

Ventilator Lung · Ventilator-Induced Lung Injury · Diaphragm Disease · Phrenic Nerve · Phrenic Nerve Stimulation · Neck Anatomy · Ultrasound

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 63 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This will be a prospective observational study where the investigator will scan patients' necks with an ultrasound and look for anatomical landmarks that may help identify the phrenic nerve.

Read the full description

Patients under protective mechanical ventilation, an intervention that saves lives, may need sedation and paralyzing agents. However, sedation and paralyzing agents are associated with multiple complications, including diaphragm dysfunction.

Several strategies have been proposed to reduce diaphram dysfunction. A novel approach is to stimulate the phrenic nerve, either transvenously or transcutaneously. Transvenous stimulation requires a catheter, which eventually is associated with increased risk of infection and thrombosis. In this scenario, transcutaneous phrenic nerve pacing is attractive but may be more susceptible to patients' anthropometric measures.

The correlation between patients' anthropometric measures and the location of the phrenic has been poorly studied.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria

Age ≥ 18 years
Admitted to ICU

Exclusion Criteria

Patients with a cervical spine collar
Patients who refuse to participate in the study

Study population

Adult patients admitted to the ICU

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

Neck ultrasound PROCEDURE

The investigators will scan patients' necks with an ultrasound and look for anatomical landmarks to identify the phrenic nerve

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

To evaluate the number of participants where the investigators will successfully identify the phrenic nerve using only ultrasound and anatomical landmarks

Time frame: 25-30 minutes