Back to resultsThe Role of Lung Ultrasound During Perioperative Evaluation
Primary Purpose
Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lung ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Diseases
Eligibility Criteria
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.
Sites / Locations
- University of Pisa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lung ultrasonography
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03111641
Brief Title
The Role of Lung Ultrasound During Perioperative Evaluation
Official Title
Comparison of Lung Ultrasound Assessment and Chest Radiography During Perioperative Evaluation: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 18, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung ultrasonography
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasonography
Intervention Description
Lung ultrasound scan during preoperative anaesthesia consultation
Primary Outcome Measure Information:
Title
Performance comparison of lung ultrasonography and chest x-ray in the detection of pleural effusion, consolidation, alveolar- interstitial syndrome.
Description
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.
Time Frame
during preoperative anaesthesia consultation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Pisa
City
Pisa
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
The Role of Lung Ultrasound During Perioperative Evaluation
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