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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diaphragm Issues Breath Shortness Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure Diaphragmatic Paralysis Dyspnea Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Reconstructive Surgery Alliance, Red Bank, New Jersey, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Age 18 and below.

Treatment and study plan

Primary outcomes

Radiographic Position of Diaphragm.

Time frame: Up to 12 Months.

Radiographic Thoracic Imaging.
Pulmonary Function.

Time frame: Up to 12 Months.

Pulmonary Function Test (PFT).

Secondary outcomes

Health-Related Quality of Life (HRQoL).

Time frame: Up to 12 Months.

SF-36 / RAND Survey.
Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.

Time frame: Up to 24 Months.

AEs related to the procedure reported in the medical chart.

Sponsors and collaborators

Lead sponsor

Advanced Reconstructive Surgery Alliance

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Feb 14, 2024
Registry last updated: Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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