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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06257589
Enrollment
700
Registered
2024-02-14
Start date
2023-10-10
Completion date
2026-10-10
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breath Shortness, Diaphragmatic Paralysis, Diaphragm Issues, Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure

Keywords

Grounded Theory, Mixed Methods, Chart Review, Diaphragmatic Paralysis

Brief summary

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

Interventions

None listed

Sponsors

Advanced Reconstructive Surgery Alliance
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years

Inclusion criteria

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

Exclusion criteria

* Age 18 and below.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic Position of Diaphragm.Up to 12 Months.Radiographic Thoracic Imaging.
Pulmonary Function.Up to 12 Months.Pulmonary Function Test (PFT).

Secondary

MeasureTime frameDescription
Health-Related Quality of Life (HRQoL).Up to 12 Months.SF-36 / RAND Survey.
Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.Up to 24 Months.AEs related to the procedure reported in the medical chart.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026