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

NCT06257589 | Active Not Recruiting DMC

• 1 other identifier: GT-Phase-1
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Radiographic Position of Diaphragm.

  Radiographic Thoracic Imaging.

  Up to 12 Months.

• Pulmonary Function.

  Pulmonary Function Test (PFT).

  Up to 12 Months.

Secondary Outcomes (2)

• Health-Related Quality of Life (HRQoL).

  Up to 12 Months.

• Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.

  Up to 24 Months.

Study Arms (2)

Intrathoracic Approach

Patients who have undergone the intrathoracic approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis. NO INTERVENTION.

Cervical Approach

Patients who have undergone the cervical approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis. NO INTERVENTION.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Age 18 and below.

Sponsors & Collaborators

• Advanced Reconstructive Surgery Alliance: lead

Study Sites (2)

Advanced Reconstructive Surgery Alliance

Red Bank, New Jersey, 07701, United States

Location

Institute for Advanced Reconstruction

Shrewsbury, New Jersey, 07702, United States

Location

Related Publications (10)

• 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.

  PMID: 36031309 BACKGROUND

• 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.

  PMID: 34397519 BACKGROUND

• 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.

  PMID: 33432336 BACKGROUND

• 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.

  PMID: 33054689 BACKGROUND

• 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.

  PMID: 22366245 BACKGROUND

• 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.

  PMID: 27665114 BACKGROUND

• 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.

  PMID: 24266954 BACKGROUND

• 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.

  PMID: 21349932 BACKGROUND

• 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.

  PMID: 23838708 BACKGROUND

• 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.

  PMID: 25868155 BACKGROUND

MeSH Terms

Conditions

Paralysis; Dyspnea; Respiratory Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Respiratory Insufficiency

Study Officials

• Matthew Kaufman, MD

  Advanced Reconstructive Surgery Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Phrenic Nerve Reconstructive Surgery.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 14, 2024
• Study Start: October 10, 2023
• Primary Completion: October 10, 2025
• Study Completion (Estimated): October 10, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)