Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Thoracic Cancer; Diaphragm Injury; Phrenic Nerve Paralysis
• Intervention / Treatment: Procedure: Lung lobectomy OR esophagus cancer resection

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for resection surgeries for either lung or esophagus cancer.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing Thoracic Surgery	Procedure: Lung lobectomy OR esophagus cancer resection; Lunge lobectomy (total) Resection of esophagus cancer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2020
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): October 30, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Paralysis; Postoperative Complications
• Other Study ID Numbers: DiaphragmaticDysfunction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No