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

November 21, 2025 updated by: Ferdane Melike Duran

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Konya
      • Konya, Konya, Turkey (Türkiye), 42080
        • Konya City Hospital, Department of Thoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phrenic crush
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
Temporary intraoperative compression (1-2 seconds) of the phrenic nerve during lobectomy to induce transient diaphragmatic paralysis and minimize postoperative residual space.
No Intervention: Control
Patients underwent standard lobectomy via muscle-sparing thoracotomy without any intraoperative manipulation or compression of the phrenic nerve.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Preoperative; 3 weeks postoperative; 6 months postoperative
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.
Preoperative; 3 weeks postoperative; 6 months postoperative
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.
Preoperative; 3 weeks postoperative; 6 months postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to postoperative day 30
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.
Up to postoperative day 30
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.
Up to postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferdane Melike Duran

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ferdane M Duran, MD, University of Health Science, Konya City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEU2019-1421 (Other Identifier: Necmettin Erbakan University Faculty of Medicine Ethics Commitee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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