Surgery, ThoracicOLVDDNCT03347578
Diaphragmatic Echography After Thoracic Surgery
An observational study of Surgery, Thoracic and Respiratory Diaphragm, run by Università degli Studi di Ferrara.
Trial summary
The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery. Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also, preoperative spirometry and postoperative spirometry were collected (24 hours after surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Thoracic, Respiratory Diaphragm, Complication, Postoperative
- What is being tested?
- Ultrasonography
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lung resection surgery for cancer
Who may be able to join
- Elective surgery for lung cancer
- Age > 18
- ASA 2-3
Who cannot join
- BMI > 35
- Contraindications for epidural catheter positioning
- History of neurodegenerative pathology
- Previous thoracic surgery
- Need for mechanical ventilation after surgery
About this study
Official title: Evaluation of Diaphragmatic Displacement With Echography in Patients Undergoing Thoracic Surgery
The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery. Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also, preoperative spirometry and postoperative spirometry were collected (24 hours after surgery).
- Being tested
- Ultrasonography
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Diaphragmatic ultrasound was performed to investigate diaphragmatic function after thoracic surgery
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer surgery | All patients undergoing thoracic surgery for lung cancer either with thoracoscopy or thoracotomy will receive diaphragmatic Ultrasonography 2 and 24 hours after surgery Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic dysfunction
Diaphragmatic dysfunction is descripted as a diaphragmatic excursione lower than 10 mm
Measured: 24 hours after surgery
Secondary outcomes (1)
Postoperative pulmonary complications
Postoperative pulmonary complications include hypoxemia, severe hypoxemia, bronchospasm, suspected pulmonary infection, new pulmonary infiltrates, atelectasis, pleural effusion
Measured: 7 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 posted20 Nov 2017
- Study startFeb 2016
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, ThoracicStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347578
- Sponsor's protocol ID
- OLV DD
- Acronym
- OLVDD
- Status last verified
- May 2018
- First submitted
- 15 Nov 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diaphragmatic Displacement With Echography in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03347578
- Acronym / sponsor ID
- OLVDD / OLV DD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Nov 2017 (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.
The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery. Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also, preoperative spirometry and postoperative spirometry were collected (24 hours after surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer surgery | – | Diagnostic Test: UltrasonographyAll patients undergoing thoracic surgery for lung cancer either with thoracoscopy or thoracotomy will receive diaphragmatic Ultrasonography 2 and 24 hours after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lung resection surgery for cancer
Key inclusion criteria (3 listed)
- Elective surgery for lung cancer
- Age > 18
- ASA 2-3
Key exclusion criteria (5 listed)
- BMI > 35
- Contraindications for epidural catheter positioning
- History of neurodegenerative pathology
- Previous thoracic surgery
- Need for mechanical ventilation after surgery
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 |
|---|---|---|
| UltrasonographyDiaphragmatic ultrasound was performed to investigate diaphragmatic function after thoracic surgery | Diagnostic test | Lung cancer surgery |
Primary outcome
Diaphragmatic dysfunction
Time frame: 24 hours after surgery
Diaphragmatic dysfunction is descripted as a diaphragmatic excursione lower than 10 mm
1 secondary outcome
Postoperative pulmonary complications
Time frame: 7 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 8 May 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Thoracic and Respiratory Diaphragm, run by Università degli Studi di Ferrara.
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 3 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 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Diaphragmatic dysfunction (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2018.