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

February 5, 2024 updated by: Matthew Kaufman, MD, Advanced Reconstructive Surgery Alliance

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Red Bank, New Jersey, United States, 07701
        • Recruiting
        • Advanced Reconstructive Surgery Alliance
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Kaufman, MD
      • Shrewsbury, New Jersey, United States, 07702
        • Recruiting
        • Institute for Advanced Reconstruction
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Kaufman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-Structured Interviews.
Time Frame: Participants are interviewed one week before and 12 months after the surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Reconstructive Surgery Alliance

Investigators

  • Principal Investigator: Matthew Kaufman, MD., Advanced Reconstructive Surgery Alliance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

October 10, 2025

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-Phase-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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