- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875883
Phrenic Identification in the ICU
Anatomical Landmarks for Identifying the Phrenic Nerve With Ultrasound in Intensive Care Unit
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laurent Brochard, MD
- Phone Number: 5686 416-864-6060
- Email: Laurent.brochard@unityhealth.to
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Age ≥ 18 years
- Admitted to ICU
Exclusion Criteria
- Patients with a cervical spine collar
- Patients who refuse to participate in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
25-30 minutes
|
To measure both phrenic nerves depth with an ultrasound in a heterogeneous population in the ICU
Time Frame: 25-30 minutes
|
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
Time Frame: 25-30 minutes
|
25-30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To describe potential clinical and anthropometric variables associated with phrenic nerve depth
Time Frame: 25-30 minutes
|
25-30 minutes
|
To assess how long it takes to find the phrenic nerve with ultrasound visualization.
Time Frame: 25-30 minutes
|
25-30 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-083 (Other Identifier: Liverpool School Tropical Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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