- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111641
The Role of Lung Ultrasound During Perioperative Evaluation
September 28, 2017 updated by: Francesco Forfori, University of Pisa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pisa, Italy
- University of Pisa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients undergoing elective general surgery;
- age >18 years;
- ability to provide written consent;
- use of Chest radiography during the preoperative evaluation.
Exclusion Criteria:
- age < than 18 year;
- pregnant patients;
- not use of Chest radiography during the preoperative evaluation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lung ultrasonography
|
Lung ultrasound scan during preoperative anaesthesia consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
during preoperative anaesthesia consultation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2017
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
September 28, 2017
Study Registration Dates
First Submitted
April 2, 2017
First Submitted That Met QC Criteria
April 7, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
September 29, 2017
Last Update Submitted That Met QC Criteria
September 28, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPisa2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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