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Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04507594
Enrollment
40
Registered
2020-08-11
Start date
2020-08-06
Completion date
2022-10-30
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Injury, Phrenic Nerve Paralysis, Postoperative Complications, Thoracic 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.

Interventions

PROCEDURELung lobectomy OR esophagus cancer resection

Lunge lobectomy (total) Resection of esophagus cancer

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in excursion of the diaphragmPrior to surgery to 14 days after surgeryUltrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm

Secondary

MeasureTime frameDescription
Ultrasonographic measure of the difference in Intrathoracic AreaPrior to surgery to 14 days after surgeryIntrathoracic Area is measured at inspiration and expiration to calculate the difference in Intrathoracic Area during breathing
Change in Diaphragmatic Thickening FractionPrior to surgery to 14 days after surgeryUltrasonographic measurement
Change in Intercostal Muscle Thickening FractionPrior to surgery to 14 days after surgeryUltrasonographic measurement
Change in forced expired volume within the first second (FEV1)Prior to surgery to 14 days after surgerySpirometry
Change in forced vital capacity (FEV)Prior to surgery to 14 days after surgerySpirometry
Change in peak flowPrior to surgery to 14 days after surgerySpirometry
Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nervePrior to surgery to 14 days after surgery
Accumulated Admission Days at any HospitalPrior to surgery to 60 days after surgery
Change in 6 Minutes Walk TestPrior to surgery to 14 days after surgeryMaximum Walking Distance within 6 minutes
Change in visual analogue scale scorePrior to surgery to 14 days after surgeryScoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations
Accumulated Opiod Use after SurgeryPrior to surgery to 14 days after surgeryMorphine equivalents
Postoperative Pulmonary ComplicationsPrior to surgery to 30 days after surgeryComprising: 1. Pneumonia 2. Atelectasis 3. Bronchospasm 4. Hypoxemia 5. Severe Hypoxemia 6. Pleural Effusion 1 \> cm 7. Pneumothorax 8. CPAP or NIV required after 1. postoperative day
Admission days at the Intensive Care Unit after SurgeryPrior to surgery to 60 days after surgery
Number of Admissions after Discharge from the Surgical DepartmentPrior to surgery to 60 days after surgery
Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nervePrior to surgery to 14 days after surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026