Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

Sponsor
Aarhus University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04507594
Collaborator
(none)
50
1
11.8
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lung lobectomy OR esophagus cancer resection

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer
Actual Study Start Date :
Aug 6, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jul 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing Thoracic Surgery

Procedure: Lung lobectomy OR esophagus cancer resection
Lunge lobectomy (total) Resection of esophagus cancer

Outcome Measures

Primary Outcome Measures

  1. Change in excursion of the diaphragm [Prior to surgery to 14 days after surgery]

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

Secondary Outcome Measures

  1. Ultrasonographic measure of the difference in Intrathoracic Area [Prior to surgery to 14 days after surgery]

    Intrathoracic Area is measured at inspiration and expiration to calculate the difference in Intrathoracic Area during breathing

  2. Change in Diaphragmatic Thickening Fraction [Prior to surgery to 14 days after surgery]

    Ultrasonographic measurement

  3. Change in Intercostal Muscle Thickening Fraction [Prior to surgery to 14 days after surgery]

    Ultrasonographic measurement

  4. Change in forced expired volume within the first second (FEV1) [Prior to surgery to 14 days after surgery]

    Spirometry

  5. Change in forced vital capacity (FEV) [Prior to surgery to 14 days after surgery]

    Spirometry

  6. Change in peak flow [Prior to surgery to 14 days after surgery]

    Spirometry

  7. Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve [Prior to surgery to 14 days after surgery]

  8. Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve [Prior to surgery to 14 days after surgery]

  9. Change in 6 Minutes Walk Test [Prior to surgery to 14 days after surgery]

    Maximum Walking Distance within 6 minutes

  10. Change in visual analogue scale score [Prior to surgery to 14 days after surgery]

    Scoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations

  11. Accumulated Opiod Use after Surgery [Prior to surgery to 14 days after surgery]

    Morphine equivalents

  12. Postoperative Pulmonary Complications [Prior to surgery to 30 days after surgery]

    Comprising: Pneumonia Atelectasis Bronchospasm Hypoxemia Severe Hypoxemia Pleural Effusion 1 > cm Pneumothorax CPAP or NIV required after 1. postoperative day

  13. Admission days at the Intensive Care Unit after Surgery [Prior to surgery to 60 days after surgery]

  14. Number of Admissions after Discharge from the Surgical Department [Prior to surgery to 60 days after surgery]

  15. Accumulated Admission Days at any Hospital [Prior to surgery to 60 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital Aarhus N Denmark 8200

Sponsors and Collaborators

  • Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Juhl-Olsen, Associate Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT04507594
Other Study ID Numbers:
  • DiaphragmaticDysfunction
First Posted:
Aug 11, 2020
Last Update Posted:
Aug 11, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2020