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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity

NCT00530491

Respiration Disorders

UNKNOWN NA

Intraoperative Neuromuscular Blockade and Postoperative Atelectasis

NCT03503565

Thoracic Surgery One-lung Ventilation

COMPLETED

Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

NCT04507594

Diaphragm Injury Phrenic Nerve Paralysis Thoracic Cancer +1 more

COMPLETED

Exercise Capacity, Pulmonary Function and Physical Activity Level in Patients Lung Cancer Undergoing Pneumonectomy

NCT04807153

Pneumonectomy; Status

COMPLETED

Effect of Periodic Alveolar Recruitment Maneuvers on Intraoperative Atelectasis in Adult Patients Undergoing Prone Lumbar Spine Surgery

NCT07325812

Atelectasis Mechanical Ventilation General Anesthesia +1 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Prolonged Air Leak Phrenic Nerve EMG

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study. Participants, surgeons, and outcome assessors are aware of group assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

İntraoperative phrenic nerve compression

Intervention Type PROCEDURE

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No