Measurement of Diaphragmatic Dysfunction After Thoracic Surgery
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2020
CompletedStudy Start
First participant enrolled
August 6, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedNovember 1, 2022
October 1, 2022
1.2 years
August 6, 2020
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Ultrasonographic measure of the difference in Intrathoracic Area
Prior to surgery to 14 days after surgery
Change in Diaphragmatic Thickening Fraction
Prior to surgery to 14 days after surgery
Change in Intercostal Muscle Thickening Fraction
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 forced vital capacity (FEV)
Prior to surgery to 14 days after surgery
- +10 more secondary outcomes
Study Arms (1)
Patients undergoing Thoracic Surgery
Interventions
Lunge lobectomy (total) Resection of esophagus cancer
Eligibility Criteria
Patients scheduled for resection surgeries for either lung or esophagus cancer.
You may qualify if:
- Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer patients, at least one lung lobe has to scheduled for resection
You may not qualify if:
- Known Diaphragmatic Dysfunction
- Neuromuscular Disease
- Pleural Effusion \> 1cm
- Pneumothorax
- Known Phrenic Nerve Palsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital
Aarhus N, 8200, Denmark
Related Publications (1)
Norskov J, Skaarup SH, Bendixen M, Tankisi H, Morkved AL, Juhl-Olsen P. Diaphragmatic dysfunction is associated with postoperative pulmonary complications and phrenic nerve paresis in patients undergoing thoracic surgery. J Anesth. 2024 Jun;38(3):386-397. doi: 10.1007/s00540-024-03325-5. Epub 2024 Mar 28.
PMID: 38546897DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 6, 2020
First Posted
August 11, 2020
Study Start
August 6, 2020
Primary Completion
October 1, 2021
Study Completion
October 30, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10