Clinical trial NCT05875883: Phrenic Identification in the ICU
Official title: Anatomical Landmarks for Identifying the Phrenic Nerve With Ultrasound in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ventilator Lung
Ventilator-Induced Lung Injury
Diaphragm Disease
Phrenic Nerve
Phrenic Nerve Stimulation
Neck Anatomy
Ultrasound
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the ICU

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.

Eligibility criteria: Inclusion Criteria

* Age ≥ 18 years
* Admitted to ICU

Exclusion Criteria

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

Primary outcomes:
measure: To evaluate the number of participants where the investigators will successfully identify the phrenic nerve using only ultrasound and anatomical landmarks
timeFrame: 25-30 minutes
measure: To measure both phrenic nerves depth with an ultrasound in a heterogeneous population in the ICU
timeFrame: 25-30 minutes
measure: To measure the distance, in milimeters, between each phrenic nerve and other homolateral cervical structures such as the carotid artery and the jugular vein
timeFrame: 25-30 minutes
Secondary outcomes:
measure: To describe potential clinical and anthropometric variables associated with phrenic nerve depth
timeFrame: 25-30 minutes
measure: To assess how long it takes to find the phrenic nerve with ultrasound visualization.
timeFrame: 25-30 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
citation: 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.
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.
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, 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.