Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

Completed

• Conditions: Thoracic Cancer; Phrenic Nerve Paralysis; Postoperative Complications; Diaphragm Injury
• Interventions: Procedure: Lung lobectomy OR esophagus cancer resection

• Registration Number: NCT04507594
• Lead Sponsor: Aarhus University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-06
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-09
• Study First Posted: 2020-08-11
• Primary Completion: 2021-10-01
• Status Verified: 2022-10
• Study Completion: 2022-10-30
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing Thoracic Surgery	Lung lobectomy OR esophagus cancer resection	-

Primary Outcome Measures

Name	Time	Method
Change in excursion of the diaphragm	Prior to surgery to 14 days after surgery	Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm

Secondary Outcome Measures

Name	Time	Method
Change in Diaphragmatic Thickening Fraction	Prior to surgery to 14 days after surgery	Ultrasonographic measurement
Change in peak flow	Prior to surgery to 14 days after surgery	Spirometry
Ultrasonographic measure of the difference in Intrathoracic Area	Prior to surgery to 14 days after surgery	Intrathoracic Area is measured at inspiration and expiration to calculate the difference in Intrathoracic Area during breathing
Change in forced expired volume within the first second (FEV1)	Prior to surgery to 14 days after surgery	Spirometry
Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve	Prior to surgery to 14 days after surgery
Postoperative Pulmonary Complications	Prior to surgery to 30 days after surgery	Comprising: 1. Pneumonia; 2. Atelectasis; 3. Bronchospasm; 4. Hypoxemia; 5. Severe Hypoxemia; 6. Pleural Effusion 1 \> cm; 7. Pneumothorax; 8. CPAP or NIV required after 1. postoperative day
Change in forced vital capacity (FEV)	Prior to surgery to 14 days after surgery	Spirometry
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	Prior to surgery to 14 days after surgery	Maximum Walking Distance within 6 minutes
Accumulated Opiod Use after Surgery	Prior to surgery to 14 days after surgery	Morphine equivalents
Admission days at the Intensive Care Unit after Surgery	Prior to surgery to 60 days after surgery
Accumulated Admission Days at any Hospital	Prior to surgery to 60 days after surgery
Change in Intercostal Muscle Thickening Fraction	Prior to surgery to 14 days after surgery	Ultrasonographic measurement
Change in visual analogue scale score	Prior to surgery to 14 days after surgery	Scoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations
Number of Admissions after Discharge from the Surgical Department	Prior to surgery to 60 days after surgery

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark