Clinical Trials Directory

Trials / Completed

CompletedNCT07259031

Postoperative Effects of Intraoperative Temporary Phrenic Nerve Paralysis in Lung Resection Surgery

Postoperative Effects of Phrenic Nerve Paralysis Induced During Resection Surgery: A Prospective Study With Electromyography

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Ferdane Melike Duran · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This prospective clinical study aimed to evaluate the postoperative effects of temporary phrenic nerve paralysis induced by intraoperative phrenic nerve crush during lung resection surgery. The study compared postoperative pulmonary function, diaphragm activity, and clinical outcomes between patients who underwent intraoperative phrenic nerve crush and those who did not. The objective was to assess the reversibility, safety, and clinical impact of temporary phrenic nerve paralysis in relation to postoperative residual pleural space and prolonged air leak.

Detailed description

This prospective observational study was conducted at the University of Health Sciences, Konya City Hospital, Department of Thoracic Surgery, between September 2019 and March 2023. The study included patients who underwent lung resection surgery via muscle-sparing thoracotomy. In the intervention group, a controlled intraoperative phrenic nerve crush was applied to induce temporary phrenic nerve paralysis. In the control group, no phrenic nerve manipulation was performed. The primary objective was to evaluate the postoperative effects and reversibility of temporary phrenic nerve paralysis using diaphragm electromyography (EMG) and pulmonary function tests (FEV1, FVC). Secondary objectives included the assessment of residual pleural space filling, prolonged air leak, chest tube duration, and length of hospital stay. The study also aimed to determine whether temporary phrenic nerve paralysis could help minimize postoperative residual pleural space and prolonged air leak without causing permanent functional impairment. Ethical approval for the study was obtained from the Necmettin Erbakan University Faculty of Medicine Ethics Committee (approval number: NEU2019-1421). Written informed consent was obtained from all participants prior to enrollment.

Conditions

Interventions

TypeNameDescription
PROCEDUREİntraoperative phrenic nerve compressionTemporary intraoperative compression (1-2 seconds) of the phrenic nerve during lobectomy to induce transient diaphragmatic paralysis and minimize postoperative residual space.

Timeline

Start date
2019-09-01
Primary completion
2023-03-31
Completion
2023-06-30
First posted
2025-12-02
Last updated
2025-12-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07259031. Inclusion in this directory is not an endorsement.