Phrenic Identification in the ICU

NCT05875883 | Active Not Recruiting

• 1 other identifier: 23-083
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Interventions

Neck ultrasound PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the ICU

You may qualify if:

• Age ≥ 18 years
• Admitted to ICU

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (3)

• 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.

  PMID: 10793162 BACKGROUND

• 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.

  PMID: 27500981 BACKGROUND

• 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.

  PMID: 35108175 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 25, 2023
• Study Start: April 21, 2024
• Primary Completion (Estimated): December 4, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)