A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis

Diaphragmatic Paralysis Clinical Trial

Official title:

A Grounded Theory of Phrenic Nerve Reconstruction for the Treatment of Diaphragm Paralysis - A Biopsychosocial Approach to Surgical Evaluation and Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06257589
• Other study ID #: GT-Phase-1
• Status: Active, not recruiting
• Start date: October 10, 2023
• Est. completion date: October 10, 2026

Study information

• Verified date: February 2024
• Source: Advanced Reconstructive Surgery Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: October 10, 2026
• Est. primary completion date: October 10, 2025
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age 18 and below.

Related Conditions & MeSH terms

• Breath Shortness
• Diaphragm Issues
• Diaphragmatic Paralysis
• Dyspnea
• Paralysis
• Respiratory Paralysis

Locations

Country	Name	City	State
United States	Advanced Reconstructive Surgery Alliance	Red Bank	New Jersey
United States	Institute for Advanced Reconstruction	Shrewsbury	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Reconstructive Surgery Alliance

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. Erratum In: J Reconstr Microsurg. 2017 Jan;33(1):e1-e2. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Position of Diaphragm.	Radiographic Thoracic Imaging.	Up to 12 Months.
Primary	Pulmonary Function.	Pulmonary Function Test (PFT).	Up to 12 Months.
Secondary	Health-Related Quality of Life (HRQoL).	SF-36 / RAND Survey.	Up to 12 Months.
Secondary	Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.	AEs related to the procedure reported in the medical chart.	Up to 24 Months.