Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

Study Overview
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Brief Summary
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This study aims to measure diaphragmatic dysfunction with ultrasonography and nerve stimulation of the phrenicus nerve, in patients undergoing thoracic surgery for lung and esophageal cancer, and correlate measures of diaphramatic function to clinical postoperative endpoints.

Official Title
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Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer

Conditions
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Diaphragm Injury, Phrenic Nerve Paralysis, Thoracic Cancer, Postoperative Complications

Intervention / Treatment
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* Procedure: Lung lobectomy OR esophagus cancer resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer patients, at least one lung lobe has to scheduled for resection Exclusion Criteria: Known Diaphragmatic Dysfunction Neuromuscular Disease Pleural Effusion > 1cm Pneumothorax Known Phrenic Nerve Palsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing Thoracic Surgery<br> | Procedure: Lung lobectomy OR esophagus cancer resection<br>* Lunge lobectomy (total) Resection of esophagus cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in excursion of the diaphragm | Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm | Prior to surgery to 14 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic measure of the difference in Intrathoracic Area | Intrathoracic Area is measured at inspiration and expiration to calculate the difference in Intrathoracic Area during breathing | Prior to surgery to 14 days after surgery | 
| Change in Diaphragmatic Thickening Fraction | Ultrasonographic measurement | Prior to surgery to 14 days after surgery | 
| Change in Intercostal Muscle Thickening Fraction | Ultrasonographic measurement | Prior to surgery to 14 days after surgery | 
| Change in forced expired volume within the first second (FEV1) | Spirometry | Prior to surgery to 14 days after surgery | 
| Change in forced vital capacity (FEV) | Spirometry | Prior to surgery to 14 days after surgery | 
| Change in peak flow | Spirometry | Prior to surgery to 14 days after surgery | 
| Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve |  | Prior to surgery to 14 days after surgery | 
| Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve |  | Prior to surgery to 14 days after surgery | 
| Change in 6 Minutes Walk Test | Maximum Walking Distance within 6 minutes | Prior to surgery to 14 days after surgery | 
| Change in visual analogue scale score | Scoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations | Prior to surgery to 14 days after surgery | 
| Accumulated Opiod Use after Surgery | Morphine equivalents | Prior to surgery to 14 days after surgery | 
| Postoperative Pulmonary Complications | Comprising: Pneumonia Atelectasis Bronchospasm Hypoxemia Severe Hypoxemia Pleural Effusion 1 > cm Pneumothorax CPAP or NIV required after 1. postoperative day | Prior to surgery to 30 days after surgery | 
| Admission days at the Intensive Care Unit after Surgery |  | Prior to surgery to 60 days after surgery | 
| Number of Admissions after Discharge from the Surgical Department |  | Prior to surgery to 60 days after surgery | 
| Accumulated Admission Days at any Hospital |  | Prior to surgery to 60 days after surgery |