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| ID | Type | Description | Link |
|---|---|---|---|
| NEU2019-1421 | Other Identifier | Necmettin Erbakan University Faculty of Medicine Ethics Commitee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control | No Intervention | Patients underwent standard lobectomy via muscle-sparing thoracotomy without any intraoperative manipulation or compression of the phrenic nerve. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Chest Tube Duration | Duration of chest tube placement recorded as the number of postoperative days from the time of insertion until removal. Comparisons will be made between groups. | Up to postoperative day 30 |
| Length of Hospital Stay |
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Inclusion Criteria:
Adult patients (18+) who underwent lobectomy via muscle sparing thoracotomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ferdane M Duran, MD | University of Health Science, Konya City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konya City Hospital, Department of Thoracic Surgery | Konya | Konya | 42080 | Turkey (Türkiye) |
İndividual participant data will not be shared because the study includes patient-specific clinical and electrophysiological data that cannot be fully anonymized. Data will only be used for the analysis described in the approved protocol.
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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.
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This is an open-label study. Participants, surgeons, and outcome assessors are aware of group assignment.
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Total duration of hospitalization recorded as the number of days from the day of surgery until discharge. Comparisons will be made between groups.
| Up to postoperative day 30 |
| Prolonged Air Leak | Incidence of prolonged postoperative air leak, defined as an air leak lasting more than 5 days after surgery. The outcome will be recorded as the number of participants with and without prolonged air leak in each group. | Up to postoperative day 30 |