Clinical trial NCT04507594: Measurement of Diaphragmatic Dysfunction After Thoracic Surgery
Official title: Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Injury
Phrenic Nerve Paralysis
Thoracic Cancer
Postoperative Complications
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for resection surgeries for either lung or esophagus cancer.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in excursion of the diaphragm
timeFrame: Prior to surgery to 14 days after surgery
Secondary outcomes:
measure: Ultrasonographic measure of the difference in Intrathoracic Area
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in Diaphragmatic Thickening Fraction
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in Intercostal Muscle Thickening Fraction
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in forced expired volume within the first second (FEV1)
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in forced vital capacity (FEV)
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in peak flow
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in 6 Minutes Walk Test
timeFrame: Prior to surgery to 14 days after surgery
measure: Change in visual analogue scale score
timeFrame: Prior to surgery to 14 days after surgery
measure: Accumulated Opiod Use after Surgery
timeFrame: Prior to surgery to 14 days after surgery
measure: Postoperative Pulmonary Complications
timeFrame: Prior to surgery to 30 days after surgery
measure: Admission days at the Intensive Care Unit after Surgery
timeFrame: Prior to surgery to 60 days after surgery
measure: Number of Admissions after Discharge from the Surgical Department
timeFrame: Prior to surgery to 60 days after surgery
measure: Accumulated Admission Days at any Hospital
timeFrame: Prior to surgery to 60 days after surgery
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital
Study officials:
References: