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
Peter Juhl-Olsen
Associate Professor
Aarhus University Hospital
Study Sites (1)
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