Skip to main content
OpenTrials
Completed

NCT Number: NCT04507594

Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diaphragm Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Phrenic Nerve Paralysis Postoperative Complications Thoracic Cancer

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung lobectomy OR esophagus cancer resection

Procedure

Lunge lobectomy (total) Resection of esophagus cancer

Primary outcomes

  1. 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

  1. Ultrasonographic measure of the difference in Intrathoracic Area

    Time frame: 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

    Time frame: Prior to surgery to 14 days after surgery

    Ultrasonographic measurement

  3. Change in Intercostal Muscle Thickening Fraction

    Time frame: Prior to surgery to 14 days after surgery

    Ultrasonographic measurement

  4. Change in forced expired volume within the first second (FEV1)

    Time frame: Prior to surgery to 14 days after surgery

    Spirometry

  5. Change in forced vital capacity (FEV)

    Time frame: Prior to surgery to 14 days after surgery

    Spirometry

  6. Change in peak flow

    Time frame: Prior to surgery to 14 days after surgery

    Spirometry

  7. Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve

    Time frame: Prior to surgery to 14 days after surgery

  8. Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve

    Time frame: Prior to surgery to 14 days after surgery

  9. Change in 6 Minutes Walk Test

    Time frame: Prior to surgery to 14 days after surgery

    Maximum Walking Distance within 6 minutes

  10. Change in visual analogue scale score

    Time frame: 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

    Time frame: Prior to surgery to 14 days after surgery

    Morphine equivalents

  12. Postoperative Pulmonary Complications

    Time frame: 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

    Time frame: Prior to surgery to 60 days after surgery

  14. Number of Admissions after Discharge from the Surgical Department

    Time frame: Prior to surgery to 60 days after surgery

  15. Accumulated Admission Days at any Hospital

    Time frame: Prior to surgery to 60 days after surgery

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2020
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.