Prolonged Air LeakPNCrushNCT07259031
Postoperative Effects of Intraoperative Temporary Phrenic Nerve Paralysis in Lung Resection Surgery
A study testing İntraoperative phrenic nerve compression in people with Prolonged Air Leak and Phrenic Nerve, run by Ferdane Melike Duran at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Air Leak, Phrenic Nerve, EMG
- What is being tested?
- İntraoperative phrenic nerve compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya City Hospital, Department of Thoracic Surgery
Konya, Konya, 42080
About this study
Official title: 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.
Read the 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.
- Conditions
- Prolonged Air Leak, Phrenic Nerve, EMG
- Being tested
- İntraoperative phrenic nerve compression
- Keywords
- residual air space, prolonged air leak, Phrenic nerve crush, Diaphragm electromyography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntraoperative phrenic nerve compressionProcedure or surgery
Temporary intraoperative compression (1-2 seconds) of the phrenic nerve during lobectomy to induce transient diaphragmatic paralysis and minimize postoperative residual space.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Preoperative; 3 weeks postoperative; 6 months postoperative
Secondary outcomes (3)
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.
Measured: Up to postoperative day 30
Length of Hospital Stay
Total duration of hospitalization recorded as the number of days from the day of surgery until discharge. Comparisons will be made between groups.
Measured: 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.
Measured: Up to postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Sep 2019
- Primary completion31 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Air LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferdane Melike Duran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ferdane Melike Duran, Konya City Hospital
- Investigators
- Ferdane M Duran, MD, Principal investigator, University of Health Science, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259031
- Sponsor's protocol ID
- NEU2019-1421
- Other IDs
- NEU2019-1421
- Acronym
- PNCrush
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Effects of Phrenic Nerve Paralysis Induced During Resection Surgery: A Prospective Study With Electromyography
- ClinicalTrials.gov ID
- NCT07259031
- Acronym / sponsor ID
- PNCrush / NEU2019-1421
- Conditions
- Prolonged Air Leak, Phrenic Nerve, EMG
- Keywords
- residual air space, prolonged air leak, Phrenic nerve crush, Diaphragm electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ferdane Melike DuranUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phrenic crush | Experimental | Procedure: İntraoperative phrenic nerve compressionPatients underwent standard lobectomy via muscle-sparing thoracotomy with brief intraoperative compression (1-2 seconds) of the phrenic nerve to induce transient diaphragmatic paralysis. |
| Control | No intervention | –Patients underwent standard lobectomy via muscle-sparing thoracotomy without any intraoperative manipulation or compression of the phrenic nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18+) who underwent lobectomy via muscle sparing thoracotomy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| İntraoperative phrenic nerve compressionTemporary intraoperative compression (1-2 seconds) of the phrenic nerve during lobectomy to induce transient diaphragmatic paralysis and minimize postoperative residual space. | Procedure or surgery | Phrenic crush |
Primary outcome
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.
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.
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.
3 secondary outcomes
Chest Tube Duration
Time frame: Up to postoperative day 30
Length of Hospital Stay
Time frame: Up to postoperative day 30
Prolonged Air Leak
Time frame: Up to postoperative day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdane M Duran, MD principal investigator
University of Health Science, Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İntraoperative phrenic nerve compression in people with Prolonged Air Leak and Phrenic Nerve, run by Ferdane Melike Duran at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Electromyography (time frame: Preoperative; 3 weeks postoperative; 6 months postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.