Phrenic Identification in the ICU

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05875883
• Other study ID #: 23-083
• Status: Not yet recruiting
• Start date: August 7, 2023
• Est. completion date: December 4, 2023

Study information

• Verified date: May 2023
• Source: Unity Health Toronto
• Contact: Laurent Brochard, MD
• Phone: 416-864-6060
• Email: Laurent.Brochard[@]unityhealth.to
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: December 4, 2023
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age = 18 years
• Admitted to ICU Exclusion Criteria
• Patients with a cervical spine collar
• Patients who refuse to participate in the study

Related Conditions & MeSH terms

• Diaphragm Disease
• Lung Injury
• Ultrasound
• Ventilator Lung
• Ventilator-Induced Lung Injury

Intervention

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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

References & 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 sy — View Citation

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, Mezia — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the number of participants where the investigators will successfully identify the phrenic nerve using only ultrasound and anatomical landmarks		25-30 minutes
Primary	To measure both phrenic nerves depth with an ultrasound in a heterogeneous population in the ICU		25-30 minutes
Primary	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	To describe potential clinical and anthropometric variables associated with phrenic nerve depth		25-30 minutes
Secondary	To assess how long it takes to find the phrenic nerve with ultrasound visualization.		25-30 minutes