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.
This study utilizes a grounded theory methodology to explore patient experiences of phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Advanced Reconstructive Surgery Alliance | Red Bank | New Jersey |
United States | Institute for Advanced Reconstruction | Shrewsbury | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Advanced Reconstructive Surgery Alliance |
United States,
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
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04173364 -
Interscalene Block and Dysfunction Diaphragmatic
|
Phase 3 | |
Active, not recruiting |
NCT06257589 -
A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis
|
||
Active, not recruiting |
NCT06146179 -
Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block In Shoulder Arthroplasty Surgery
|
||
Completed |
NCT05442814 -
Anterior and Posterior Approaches of Suprascapular Nerve Block
|
N/A | |
Enrolling by invitation |
NCT01569217 -
Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction
|
N/A | |
Completed |
NCT01385384 -
Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries
|
N/A | |
Recruiting |
NCT05444517 -
Interscalene Block Versus Combined Infraclavicular-Anterior Suprascapular Blocks for Shoulder Surgery
|
N/A | |
Completed |
NCT03463798 -
Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
|
||
Completed |
NCT03224884 -
Interscalene Block Versus Supraclavicular Block for Shoulder Surgery
|
N/A | |
Completed |
NCT04563468 -
Effects of Inspiratory Muscle Training on Exertional Breathlessness in Patients With Unilateral Diaphragm Paralysis
|
N/A | |
Completed |
NCT00597298 -
Diaphragm Training Post-Cardiac Surgery
|
N/A | |
Completed |
NCT04317235 -
Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis
|
N/A | |
Completed |
NCT04385966 -
Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block
|
Phase 3 | |
Terminated |
NCT03592056 -
Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions
|
||
Completed |
NCT03411343 -
Interscalene Block Versus Costoclavicular Block for Shoulder Surgery
|
N/A |