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Active, not recruitingNCT05875883Updated May 20, 2025

Phrenic Identification in the ICU

An observational study in Ventilator Lung, Ventilator-Induced Lung Injury and Diaphragm Disease, sponsored by Unity Health Toronto. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Unity Health Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventilator Lung
  • Ventilator-Induced Lung Injury
  • Diaphragm Disease
  • Phrenic Nerve
  • Phrenic Nerve Stimulation
  • Neck Anatomy
  • Ultrasound
03

In context

Lung Injury

399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.

This study's planned enrollment of 63 is close to the median of 70 across 136 observational studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients admitted to the ICU

Inclusion criteria

  • Age ≥ 18 years
  • Admitted to ICU

Exclusion criteria

Exclusion Criteria

  • Patients with a cervical spine collar
  • Patients who refuse to participate in the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (estimated)
Patient registry
No

Interventions

  • ProcedureNeck ultrasound

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

06

What researchers measure

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

07

Study locations

1 site
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
08

References and documents

Publications

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. PubMed 10793162 ↗
  • Reynolds SC, Meyyappan R, Thakkar V, Tran BD, Nolette MA, Sadarangani G, Sandoval RA, Bruulsema L, Hannigan B, Li JW, Rohrs E, Zurba J, Hoffer JA. Mitigation of Ventilator-induced Diaphragm Atrophy by Transvenous Phrenic Nerve Stimulation. Am J Respir Crit Care Med. 2017 Feb 1;195(3):339-348. doi: 10.1164/rccm.201502-0363OC. PubMed 27500981 ↗
  • Dres M, de Abreu MG, Merdji H, Muller-Redetzky H, Dellweg D, Randerath WJ, Mortaza S, Jung B, Bruells C, Moerer O, Scharffenberg M, Jaber S, Besset S, Bitter T, Geise A, Heine A, Malfertheiner MV, Kortgen A, Benzaquen J, Nelson T, Uhrig A, Moenig O, Meziani F, Demoule A, Similowski T; RESCUE-2 Study Group Investigators. Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients. Am J Respir Crit Care Med. 2022 May 15;205(10):1169-1178. doi: 10.1164/rccm.202107-1709OC. PubMed 35108175 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05875883
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
May 25, 2023
Start date
Apr 21, 2024
Primary completion
Dec 4, 2026 (estimated)
Completion
Dec 4, 2026 (estimated)
Last update
May 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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