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

NCT07259031 | Completed

• 1 other identifier: NEU2019-1421
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolonged Air Leak; Phrenic Nerve; EMG

Keywords

residual air space; prolonged air leak; Phrenic nerve crush; Diaphragm electromyography

Outcome Measures

Primary Outcomes (3)

• Diaphragmatic Electromyography

  Quantitative assesment of diaphragmatic muscle activity using preoperative and postoperative EMG, recorded as motor unit action potential amplitude (mA) and duration (ms), to evaluate the degree of diaphragmatic dysfunction or recovery following intraoperative phrenic nerve compression.

  Preoperative; 3 weeks postoperative; 6 months postoperative

• Pulmonary Function Test - FEV1

  Spirometric assessment of forced expiratory volume in 1 second (FEV1) to evaluate postoperative respiratory performance and the potential impact of brief intraoperative phrenic nerve compression. FEV1 values will be recorded as absolute volume (L) and as percent predicted (% predicted). Comparisons will be made between groups at each time point.

  Preoperative; 3 weeks postoperative; 6 months postoperative

• Pulmonary Function Test - FVC

  Spirometric assessment of forced vital capacity (FVC) to evaluate postoperative respiratory performance and the potential impact of brief intraoperative phrenic nerve compression. FVC values will be recorded as absolute volume (L) and as percent predicted (% predicted). Comparisons will be made between groups at each time point.

  Preoperative; 3 weeks postoperative; 6 months postoperative

Secondary Outcomes (3)

• Chest Tube Duration

  Up to postoperative day 30

• Length of Hospital Stay

  Up to postoperative day 30

• Prolonged Air Leak

  Up to postoperative day 30

Study Arms (2)

Phrenic crush

EXPERIMENTAL

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

Procedure: İntraoperative phrenic nerve compression

Control

NO INTERVENTION

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

Interventions

İntraoperative phrenic nerve compression PROCEDURE

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

Phrenic crush

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferdane Melike Duran: lead

Study Sites (1)

Konya City Hospital, Department of Thoracic Surgery

Konya, Konya, 42080, Turkey (Türkiye)

Location

Study Officials

• Ferdane M Duran, MD

  University of Health Science, Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, surgeons, and outcome assessors are aware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of Thoracic Surgery

Model Details: This study was designed as a parallel, two-arm interventional trial comparing patients undergoing lobectomy with or without brief intraoperative phrenic nerve compression. Participants were assigned to either the experimental group (phrenic nerve compression for 1-2 seconds) or the control group (no phrenic nerve manipulation). Postoperative respiratory function, diaphragmatic EMG findings, and clinical follow-up parameters were compared between the groups.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: September 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)