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Recruiting NCT06243718

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

— Observational Diaphragmatic Paralysis Pain, Chest Breath Shortness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diaphragmatic Paralysis, Pain, Chest, Breath Shortness. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • Semi-Structured Interviews. [Time frame: Participants are interviewed one week before and 12 months after the surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Advanced Reconstructive Surgery Alliance — Red Bank
  • Institute for Advanced Reconstruction — Shrewsbury

Publications

  • 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
  • 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
  • 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. PMID 25834691
  • 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
  • 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
  • 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
  • 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
  • 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. PMID 28709166

Identifiers

NCT: NCT06243718 · GT-Phase-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗