Lung DiseasesNCT03111641
The Role of Lung Ultrasound During Perioperative Evaluation
A study testing Lung ultrasonography in people with Lung Diseases, run by University of Pisa at 1 site in Italy.
Trial summary
Accurate pre-operative lung assessment is important to decide the most appropriate anesthesia plan. Until now, chest X-ray is considered the standard of care for lung assessment during perioperative evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Lung ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2017to 28 Sep 2017
- Phase
- Interventional
- 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
Who may be able to join
- adult patients undergoing elective general surgery;
- age >18 years;
- ability to provide written consent;
- use of Chest radiography during the preoperative evaluation.
Who cannot join
- age < than 18 year;
- pregnant patients;
- not use of Chest radiography during the preoperative evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Lung Ultrasound Assessment and Chest Radiography During Perioperative Evaluation: a Prospective Study
Accurate pre-operative lung assessment is important to decide the most appropriate anesthesia plan. Until now, chest X-ray is considered the standard of care for lung assessment during perioperative evaluation. However, lung ultrasound is a rapid, simple, non-invasive, radiation-free imaging modality and can be used as an alternative to chest radiography for the diagnosis and follow-up of various lung diseases. Moreover, the decreased radiation exposure represents a considerable improvement in patient safety. Consequently, we decided to compare the data obtained from the lung ultrasound and the chest X-ray.
- Conditions
- Lung Diseases
- Being tested
- Lung ultrasonography
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasonographyDiagnostic test
Lung ultrasound scan during preoperative anaesthesia consultation
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasonography | Experimental | Not described Receives: Diagnostic Test: Lung ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance comparison of lung ultrasonography and chest x-ray in the detection of pleural effusion, consolidation, alveolar- interstitial syndrome.
The primary objective of this project is to evaluate the possible correlation between the data obtained from the ultrasound scan and the data obtained from the chest X-ray.
Measured: during preoperative anaesthesia consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start18 Jun 2017
- Primary completion1 Aug 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Forfori, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111641
- Sponsor's protocol ID
- UPisa2017
- Status last verified
- Sep 2017
- First submitted
- 2 Apr 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Ultrasound Assessment and Chest Radiography During Perioperative Evaluation: a Prospective Study
- ClinicalTrials.gov ID
- NCT03111641
- Acronym / sponsor ID
- UPisa2017
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 18 Jun 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 13 Apr 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.
Accurate pre-operative lung assessment is important to decide the most appropriate anesthesia plan. Until now, chest X-ray is considered the standard of care for lung assessment during perioperative evaluation. However, lung ultrasound is a rapid, simple, non-invasive, radiation-free imaging modality and can be used as an alternative to chest radiography for the diagnosis and follow-up of various lung diseases. Moreover, the decreased radiation exposure represents a considerable improvement in patient safety. Consequently, we decided to compare the data obtained from the lung ultrasound and the chest X-ray.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasonography | Experimental | Diagnostic Test: Lung ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients undergoing elective general surgery;
- age >18 years;
- ability to provide written consent;
- use of Chest radiography during the preoperative evaluation.
Key exclusion criteria (3 listed)
- age < than 18 year;
- pregnant patients;
- not use of Chest radiography during the preoperative evaluation.
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 ultrasonographyLung ultrasound scan during preoperative anaesthesia consultation | Diagnostic test | Lung ultrasonography |
Primary outcome
Performance comparison of lung ultrasonography and chest x-ray in the detection of pleural effusion, consolidation, alveolar- interstitial syndrome.
Time frame: during preoperative anaesthesia consultation
The primary objective of this project is to evaluate the possible correlation between the data obtained from the ultrasound scan and the data obtained from the chest X-ray.
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 29 Sep 2017.
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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?
A study testing Lung ultrasonography in people with Lung Diseases, run by University of Pisa at 1 site in Italy.
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 4 inclusion and 3 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 29 Sep 2017. 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 Italy. 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?
Performance comparison of lung ultrasonography and chest x-ray in the detection of pleural effusion, consolidation, alveolar- interstitial syndrome. (time frame: during preoperative anaesthesia consultation). 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 29 Sep 2017.