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NCT Number: NCT07259031

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

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.

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Key information

Conditions

Prolonged Air Leak EMG Phrenic Nerve

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital, Department of Thoracic Surgery

Konya, 42080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diaphragmatic Electromyography

    Time frame: Preoperative; 3 weeks postoperative; 6 months postoperative

    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.

  2. Pulmonary Function Test - FEV1

    Time frame: Preoperative; 3 weeks postoperative; 6 months postoperative

    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.

  3. Pulmonary Function Test - FVC

    Time frame: Preoperative; 3 weeks postoperative; 6 months postoperative

    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.

Secondary outcomes

  1. Chest Tube Duration

    Time frame: Up to postoperative day 30

    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.

  2. Length of Hospital Stay

    Time frame: Up to postoperative day 30

    Total duration of hospitalization recorded as the number of days from the day of surgery until discharge. Comparisons will be made between groups.

  3. Prolonged Air Leak

    Time frame: Up to postoperative day 30

    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.

Sponsors and collaborators

Lead sponsor

Ferdane Melike Duran

Other

Registry information

Official study title

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

Acronym: PNCrush

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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