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

Ferdane Melike Duran

Status: Completed

Conditions: EMG; Prolonged Air Leak; Phrenic Nerve

Treatments: Procedure: İntraoperative phrenic nerve compression

Study type: Interventional

Funder types: Other

Identifiers

NCT07259031

NEU2019-1421 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18+) who underwent lobectomy via muscle sparing thoracotomy

  • Patients with adequate preoperative pulmonary function to tolerate lobectomy
  • Patients who provided written informed consent for participation.
  • Patients with available postoperative follow-up data, including EMG and pulmonary function tests

Exclusion criteria

• Patients who underwent wedge resection, segmentectomy, pneumonectomy, or VATS procedures
• Patients with previous phrenic nerve injury, diaphragmatic paralysis, or neuromuscular disorders affecting respiratory muscles.
• Patients with incomplete postoperative follow-up or missing EMG/PFT data

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Phrenic crush

Experimental group

Description:

Patients underwent standard lobectomy via muscle-sparing thoracotomy with brief intraoperative compression (1-2 seconds) of the phrenic nerve to induce transient diaphragmatic paralysis.

Treatment:

Procedure: İntraoperative phrenic nerve compression

Control

No Intervention group

Description:

Patients underwent standard lobectomy via muscle-sparing thoracotomy without any intraoperative manipulation or compression of the phrenic nerve.