Diaphragm InjuryNCT04507594
Measurement of Diaphragmatic Dysfunction After Thoracic Surgery
An observational study of Diaphragm Injury and Phrenic Nerve Paralysis, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diaphragm Injury, Phrenic Nerve Paralysis, Thoracic Cancer
- What is being tested?
- Lung lobectomy OR esophagus cancer resection
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Aug 2020to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for resection surgeries for either lung or esophagus cancer.
Who may be able to join
- Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer patients, at least one lung lobe has to scheduled for resection
Who cannot join
- Known Diaphragmatic Dysfunction
- Neuromuscular Disease
- Pleural Effusion > 1cm
- Pneumothorax
- Known Phrenic Nerve Palsy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer
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.
- Being tested
- Lung lobectomy OR esophagus cancer resection
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung lobectomy OR esophagus cancer resectionProcedure or surgery
Lunge lobectomy (total) Resection of esophagus cancer
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Thoracic Surgery | Not described Receives: Procedure: Lung lobectomy OR esophagus cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in excursion of the diaphragm
Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm
Measured: Prior to surgery to 14 days after surgery
Secondary outcomes (15)
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
Measured: Prior to surgery to 14 days after surgery
Change in Diaphragmatic Thickening Fraction
Ultrasonographic measurement
Measured: Prior to surgery to 14 days after surgery
Change in Intercostal Muscle Thickening Fraction
Ultrasonographic measurement
Measured: Prior to surgery to 14 days after surgery
Change in forced expired volume within the first second (FEV1)
Spirometry
Measured: Prior to surgery to 14 days after surgery
Change in forced vital capacity (FEV)
Spirometry
Measured: Prior to surgery to 14 days after surgery
Change in peak flow
Spirometry
Measured: Prior to surgery to 14 days after surgery
Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve
Measured: Prior to surgery to 14 days after surgery
Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve
Measured: Prior to surgery to 14 days after surgery
Change in 6 Minutes Walk Test
Maximum Walking Distance within 6 minutes
Measured: Prior to surgery to 14 days after surgery
Change in visual analogue scale score
Scoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations
Measured: Prior to surgery to 14 days after surgery
Accumulated Opiod Use after Surgery
Morphine equivalents
Measured: Prior to surgery to 14 days after surgery
Postoperative Pulmonary Complications
Comprising:
- Pneumonia
- Atelectasis
- Bronchospasm
- Hypoxemia
- Severe Hypoxemia
- Pleural Effusion 1 > cm
- Pneumothorax
- CPAP or NIV required after 1. postoperative day
Measured: Prior to surgery to 30 days after surgery
Admission days at the Intensive Care Unit after Surgery
Measured: Prior to surgery to 60 days after surgery
Number of Admissions after Discharge from the Surgical Department
Measured: Prior to surgery to 60 days after surgery
Accumulated Admission Days at any Hospital
Measured: Prior to surgery to 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start6 Aug 2020
- Primary completion1 Oct 2021
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm InjuryStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Juhl-Olsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507594
- Sponsor's protocol ID
- DiaphragmaticDysfunction
- Status last verified
- Oct 2022
- First submitted
- 6 Aug 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38546897
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04507594
- Acronym / sponsor ID
- DiaphragmaticDysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Thoracic Surgery | – | Procedure: Lung lobectomy OR esophagus cancer resection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for resection surgeries for either lung or esophagus cancer.
Key inclusion criteria (1 listed)
- Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer patients, at least one lung lobe has to scheduled for resection
Key exclusion criteria (5 listed)
- Known Diaphragmatic Dysfunction
- Neuromuscular Disease
- Pleural Effusion > 1cm
- Pneumothorax
- Known Phrenic Nerve Palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung lobectomy OR esophagus cancer resectionLunge lobectomy (total) Resection of esophagus cancer | Procedure or surgery | Patients undergoing Thoracic Surgery |
Primary outcome
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
15 secondary outcomes
Ultrasonographic measure of the difference in Intrathoracic Area
Time frame: Prior to surgery to 14 days after surgery
Change in Diaphragmatic Thickening Fraction
Time frame: Prior to surgery to 14 days after surgery
Change in Intercostal Muscle Thickening Fraction
Time frame: Prior to surgery to 14 days after surgery
Change in forced expired volume within the first second (FEV1)
Time frame: Prior to surgery to 14 days after surgery
Change in forced vital capacity (FEV)
Time frame: Prior to surgery to 14 days after surgery
Change in peak flow
Time frame: Prior to surgery to 14 days after surgery
Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve
Time frame: Prior to surgery to 14 days after surgery
Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve
Time frame: Prior to surgery to 14 days after surgery
Change in 6 Minutes Walk Test
Time frame: Prior to surgery to 14 days after surgery
Change in visual analogue scale score
Time frame: Prior to surgery to 14 days after surgery
Accumulated Opiod Use after Surgery
Time frame: Prior to surgery to 14 days after surgery
Postoperative Pulmonary Complications
Time frame: Prior to surgery to 30 days after surgery
Admission days at the Intensive Care Unit after Surgery
Time frame: Prior to surgery to 60 days after surgery
Number of Admissions after Discharge from the Surgical Department
Time frame: Prior to surgery to 60 days after surgery
Accumulated Admission Days at any Hospital
Time frame: Prior to surgery to 60 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 38546897Norskov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Injury and Phrenic Nerve Paralysis, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in excursion of the diaphragm (time frame: Prior to surgery to 14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.