A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis
NCT ID: NCT06257589
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
700 participants
OBSERVATIONAL
2023-10-10
2026-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Intrathoracic Approach
Patients who have undergone the intrathoracic approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis.
NO INTERVENTION.
No interventions assigned to this group
Cervical Approach
Patients who have undergone the cervical approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis.
NO INTERVENTION.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
95 Years
ALL
No
Sponsors
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Advanced Reconstructive Surgery Alliance
OTHER_GOV
Responsible Party
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Matthew Kaufman, MD
Head of Phrenic Nerve Reconstructive Surgery.
Principal Investigators
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Matthew Kaufman, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Reconstructive Surgery Alliance
Locations
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Advanced Reconstructive Surgery Alliance
Red Bank, New Jersey, United States
Institute for Advanced Reconstruction
Shrewsbury, New Jersey, United States
Countries
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References
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Kaufman MR, Ferro N, Paulin E. Phrenic nerve paralysis and phrenic nerve reconstruction surgery. Handb Clin Neurol. 2022;189:271-292. doi: 10.1016/B978-0-323-91532-8.00003-3.
Kaufman MR, Chang EI, Bauer T, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Phrenic Nerve Reconstruction for Effective Surgical Treatment of Diaphragmatic Paralysis. Ann Plast Surg. 2021 Sep 1;87(3):310-315. doi: 10.1097/SAP.0000000000002896.
Kaufman MR, Bauer T, Onders RP, Brown DP, Chang EI, Rossi K, Elkwood AI, Paulin E, Jarrahy R. Treatment for bilateral diaphragmatic dysfunction using phrenic nerve reconstruction and diaphragm pacemakers. Interact Cardiovasc Thorac Surg. 2021 May 10;32(5):753-760. doi: 10.1093/icvts/ivaa324.
Kaufman MR, Bauer T, Campbell S, Rossi K, Elkwood A, Jarrahy R. Prospective analysis of a surgical algorithm to achieve ventilator weaning in cervical tetraplegia. J Spinal Cord Med. 2022 Jul;45(4):531-535. doi: 10.1080/10790268.2020.1829417. Epub 2020 Oct 15.
Kaufman MR, Willekes LJ, Elkwood AI, Rose MI, Patel TR, Ashinoff RL, Colicchio AR. Diaphragm paralysis caused by transverse cervical artery compression of the phrenic nerve: the Red Cross syndrome. Clin Neurol Neurosurg. 2012 Jun;114(5):502-5. doi: 10.1016/j.clineuro.2012.01.048. Epub 2012 Feb 24.
Kaufman MR, Elkwood AI, Brown D, Cece J, Martins C, Bauer T, Weissler J, Rezzadeh K, Jarrahy R. Long-Term Follow-Up after Phrenic Nerve Reconstruction for Diaphragmatic Paralysis: A Review of 180 Patients. J Reconstr Microsurg. 2017 Jan;33(1):63-69. doi: 10.1055/s-0036-1588018. Epub 2016 Sep 25.
Kaufman MR, Elkwood AI, Colicchio AR, CeCe J, Jarrahy R, Willekes LJ, Rose MI, Brown D. Functional restoration of diaphragmatic paralysis: an evaluation of phrenic nerve reconstruction. Ann Thorac Surg. 2014 Jan;97(1):260-6. doi: 10.1016/j.athoracsur.2013.09.052. Epub 2013 Nov 19.
Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Saad A, Caccavale R, Bocage JP, Cole J, Soriano A, Fein E. Reinnervation of the paralyzed diaphragm: application of nerve surgery techniques following unilateral phrenic nerve injury. Chest. 2011 Jul;140(1):191-197. doi: 10.1378/chest.10-2765. Epub 2011 Feb 24.
Kaufman MR, Elkwood AI, Rose MI, Patel T, Ashinoff R, Fields R, Brown D. Surgical treatment of permanent diaphragm paralysis after interscalene nerve block for shoulder surgery. Anesthesiology. 2013 Aug;119(2):484-7. doi: 10.1097/ALN.0b013e31829c2f22. No abstract available.
Kaufman MR, Elkwood AI, Aboharb F, Cece J, Brown D, Rezzadeh K, Jarrahy R. Diaphragmatic reinnervation in ventilator-dependent patients with cervical spinal cord injury and concomitant phrenic nerve lesions using simultaneous nerve transfers and implantable neurostimulators. J Reconstr Microsurg. 2015 Jun;31(5):391-5. doi: 10.1055/s-0035-1549159. Epub 2015 Apr 13.
Other Identifiers
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GT-Phase-1
Identifier Type: -
Identifier Source: org_study_id
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