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Clinical Trials/NCT04507594
NCT04507594CompletedNot Applicable

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

Aarhus University Hospital1 site in 1 country40 target enrollmentStarted: August 6, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Change in excursion of the diaphragm

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in excursion of the diaphragm

Time Frame: Prior to surgery to 14 days after surgery

Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm

Secondary Outcomes

  • Change in Diaphragmatic Thickening Fraction(Prior to surgery to 14 days after surgery)
  • Change in peak flow(Prior to surgery to 14 days after surgery)
  • Ultrasonographic measure of the difference in Intrathoracic Area(Prior to surgery to 14 days after surgery)
  • Change in forced expired volume within the first second (FEV1)(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)
  • Postoperative Pulmonary Complications(Prior to surgery to 30 days after surgery)
  • Change in forced vital capacity (FEV)(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(Prior to surgery to 14 days after surgery)
  • Accumulated Opiod Use after Surgery(Prior to surgery to 14 days after surgery)
  • 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)
  • Change in visual analogue scale score(Prior to surgery to 14 days after surgery)
  • Number of Admissions after Discharge from the Surgical Department(Prior to surgery to 60 days after surgery)

Investigators

Sponsor
Aarhus University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter Juhl-Olsen

Associate Professor

Aarhus University Hospital

Study Sites (1)

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