The Role of Lung Ultrasound During Perioperative Evaluation | NCT03111641

Studies
The Role of Lung Ultrasound During Perioperative Evaluation

NCT03111641

Sponsor

University of Pisa

Status

Completed

Last Update Posted

Sep 29, 2017Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Lung Diseases

Interventions

Lung ultrasonography

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2017Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Sep 28, 2017Actual

First Submitted Date

Apr 2, 2017

First Submission Date that Met QC Criteria

Apr 7, 2017

First Posted Date

Apr 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2017

Last Update Posted Date

Sep 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung ultrasonography	Experimental		Diagnostic Test: Lung ultrasonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung ultrasonography	Diagnostic Test	Lung ultrasound scan during preoperative anaesthesia consultation	Lung ultrasonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	during preoperative anaesthesia consultation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided