Phrenic Identification in the ICU

Active, not recruiting

• Conditions: Ventilator-Induced Lung Injury; Phrenic Nerve; Ultrasound; Ventilator Lung; Diaphragm Disease; Neck Anatomy; Phrenic Nerve Stimulation

• Registration Number: NCT05875883
• Lead Sponsor: Unity Health Toronto

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Study Start: 2024-04-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-12-04
• Study Completion: 2026-12-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the number of participants where the investigators will successfully identify the phrenic nerve using only ultrasound and anatomical landmarks	25-30 minutes
To measure both phrenic nerves depth with an ultrasound in a heterogeneous population in the ICU	25-30 minutes
To measure the distance, in milimeters, between each phrenic nerve and other homolateral cervical structures such as the carotid artery and the jugular vein	25-30 minutes

Secondary Outcome Measures

Name	Time	Method
To describe potential clinical and anthropometric variables associated with phrenic nerve depth	25-30 minutes
To assess how long it takes to find the phrenic nerve with ultrasound visualization.	25-30 minutes

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada