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CompletedNCT04507594Updated Nov 1, 2022

Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

An observational study in Diaphragm Injury, Phrenic Nerve Paralysis and Thoracic Cancer, sponsored by Aarhus University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by Aarhus University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diaphragm Injury
  • Phrenic Nerve Paralysis
  • Thoracic Cancer
  • Postoperative Complications
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 199 observational studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients scheduled for resection surgeries for either lung or esophagus cancer.

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

Exclusion Criteria:

  • Known Diaphragmatic Dysfunction
  • Neuromuscular Disease
  • Pleural Effusion > 1cm
  • Pneumothorax
  • Known Phrenic Nerve Palsy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients undergoing Thoracic Surgery

    Procedure: Lung lobectomy OR esophagus cancer resection

Interventions

  • ProcedureLung lobectomy OR esophagus cancer resection

    Lunge lobectomy (total) Resection of esophagus cancer

06

What researchers measure

Primary outcomes

  1. Change in excursion of the diaphragm

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

    Time frame: Prior to surgery to 14 days after surgery

Secondary outcomes

  1. Ultrasonographic measure of the difference in Intrathoracic Area

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

    Time frame: Prior to surgery to 14 days after surgery

  2. Change in Diaphragmatic Thickening Fraction

    Ultrasonographic measurement

    Time frame: Prior to surgery to 14 days after surgery

  3. Change in Intercostal Muscle Thickening Fraction

    Ultrasonographic measurement

    Time frame: Prior to surgery to 14 days after surgery

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

    Spirometry

    Time frame: Prior to surgery to 14 days after surgery

  5. Change in forced vital capacity (FEV)

    Spirometry

    Time frame: Prior to surgery to 14 days after surgery

  6. Change in peak flow

    Spirometry

    Time frame: Prior to surgery to 14 days after surgery

  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

    Maximum Walking Distance within 6 minutes

    Time frame: Prior to surgery to 14 days after surgery

  10. Change in visual analogue scale score

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

    Time frame: Prior to surgery to 14 days after surgery

  11. Accumulated Opiod Use after Surgery

    Morphine equivalents

    Time frame: Prior to surgery to 14 days after surgery

  12. Postoperative Pulmonary Complications

    Comprising: 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

    Time frame: Prior to surgery to 30 days after surgery

  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

07

Study locations

1 site
  • Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital
    Aarhus N, 8200, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04507594
Lead sponsor
Aarhus University Hospital
Responsible party
Peter Juhl-Olsen (Associate Professor, Aarhus University Hospital) — Principal investigator
First posted
Aug 11, 2020
Start date
Aug 6, 2020
Primary completion
Oct 1, 2021
Completion
Oct 30, 2022
Last update
Nov 1, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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