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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06243718
Other study ID # GT-Phase-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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 allClick 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.
See also
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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