Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507594
• Other study ID #: DiaphragmaticDysfunction
• Status: Completed
• Start date: August 6, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: October 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Injury
• Paralysis
• Phrenic Nerve Paralysis
• Postoperative Complications
• Thoracic Cancer

Intervention

Procedure:
• Lung lobectomy OR esophagus cancer resection
Lunge lobectomy (total) Resection of esophagus cancer

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in Diaphragmatic Thickening Fraction	Ultrasonographic measurement	Prior to surgery to 14 days after surgery
Secondary	Change in Intercostal Muscle Thickening Fraction	Ultrasonographic measurement	Prior to surgery to 14 days after surgery
Secondary	Change in forced expired volume within the first second (FEV1)	Spirometry	Prior to surgery to 14 days after surgery
Secondary	Change in forced vital capacity (FEV)	Spirometry	Prior to surgery to 14 days after surgery
Secondary	Change in peak flow	Spirometry	Prior to surgery to 14 days after surgery
Secondary	Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve		Prior to surgery to 14 days after surgery
Secondary	Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve		Prior to surgery to 14 days after surgery
Secondary	Change in 6 Minutes Walk Test	Maximum Walking Distance within 6 minutes	Prior to surgery to 14 days after surgery
Secondary	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
Secondary	Accumulated Opiod Use after Surgery	Morphine equivalents	Prior to surgery to 14 days after surgery
Secondary	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
Secondary	Admission days at the Intensive Care Unit after Surgery		Prior to surgery to 60 days after surgery
Secondary	Number of Admissions after Discharge from the Surgical Department		Prior to surgery to 60 days after surgery
Secondary	Accumulated Admission Days at any Hospital		Prior to surgery to 60 days after surgery