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Active, Not Recruiting

NCT Number: NCT05875883

Phrenic Identification in the ICU

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ventilator Lung Diaphragm Disease Lung Diseases Lung Injury Neck Anatomy Phrenic Nerve Phrenic Nerve Stimulation Respiratory Tract Diseases Ultrasound Ventilator-Induced Lung Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Admitted to ICU

Exclusion criteria

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

Treatment and study plan

Neck ultrasound

Procedure

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

Primary outcomes

  1. 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

  2. To measure both phrenic nerves depth with an ultrasound in a heterogeneous population in the ICU

    Time frame: 25-30 minutes

  3. To measure the distance, in milimeters, between each phrenic nerve and other homolateral cervical structures such as the carotid artery and the jugular vein

    Time frame: 25-30 minutes

Secondary outcomes

  1. To describe potential clinical and anthropometric variables associated with phrenic nerve depth

    Time frame: 25-30 minutes

  2. To assess how long it takes to find the phrenic nerve with ultrasound visualization.

    Time frame: 25-30 minutes

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Anatomical Landmarks for Identifying the Phrenic Nerve With Ultrasound in Intensive Care Unit

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 25, 2023
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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