Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis: Patient Experiences and Reported Outcomes.

Diaphragmatic Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243718
• Other study ID #: GT-Phase-2
• Status: Recruiting
• Start date: October 10, 2023
• Est. completion date: October 10, 2026

Study information

• Verified date: February 2024
• Source: Advanced Reconstructive Surgery Alliance
• Contact: Jeannine Sico, RN.
• Phone: 732-741-0970
• Email: jsico[@]arsahealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study utilizes a grounded theory methodology to explore patient experiences of phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 10, 2026
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Individuals with a confirmed diagnosis of Diaphragmatic Paralysis.
• Individuals who are scheduled to undergo phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.

Exclusion Criteria:

• Individuals who do not comprehend the English language.

Related Conditions & MeSH terms

• Breath Shortness
• Chest Pain
• Diaphragmatic Paralysis
• Dyspnea
• Pain, Chest
• 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 (12)

Cece J, Aboharb F, Rezzadeh KS, Brown D, Jarrahy R, Kaufman MR. Klippel-feil syndrome and unilateral diaphragmatic paralysis. Eplasty. 2015 Feb 10;15:ic10. eCollection 2015. No abstract available. — View 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. — 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. Erratum to: Long-Term Follow-Up after Phrenic Nerve Reconstruction for Diaphragmatic Paralysis: A Review of 180 Patients. J Reconstr Microsurg. 2017 Jan;33(1):e1-e2. doi: 10.1055/s-0037-1604271. Epub 2017 Jul 14. — 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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-Structured Interviews.	The interviews will serve a dual purpose: first, to delve into the daily experiences of individuals living with diaphragmatic paralysis, aiming to uncover the practical and emotional realities they face; and second, to explore the experiences and perceived outcomes of phrenic nerve surgery as a treatment for diaphragmatic paralysis.	Participants are interviewed one week before and 12 months after the surgery.