Clinical trial NCT06257589: A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis
Official title: A Grounded Theory of Phrenic Nerve Reconstruction for the Treatment of Diaphragm Paralysis - A Biopsychosocial Approach to Surgical Evaluation and Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diaphragm Issues
Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure
Breath Shortness
Diaphragmatic Paralysis
Keywords: Grounded Theory
Mixed Methods
Chart Review
Diaphragmatic Paralysis
Lead sponsor: Advanced Reconstructive Surgery Alliance
Sponsor class: OTHER_GOV
First posted: 2024-02-14
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.

Brief summary: A retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.

Exclusion Criteria:

* Age 18 and below.

Primary outcomes:
measure: Radiographic Position of Diaphragm.
timeFrame: Up to 12 Months.
measure: Pulmonary Function.
timeFrame: Up to 12 Months.
Secondary outcomes:
measure: Health-Related Quality of Life (HRQoL).
timeFrame: Up to 12 Months.
measure: Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.
timeFrame: Up to 24 Months.
Other outcomes:
Locations:
city: Red Bank
country: United States
facility: Advanced Reconstructive Surgery Alliance
state: New Jersey
city: Shrewsbury
country: United States
facility: Institute for Advanced Reconstruction
state: New Jersey
Study officials:
affiliation: Advanced Reconstructive Surgery Alliance
name: Matthew Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.