NCT03111641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 18, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

April 2, 2017

Last Update Submit

September 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Lung ultrasonography

EXPERIMENTAL
Diagnostic Test: Lung ultrasonography

Interventions

Lung ultrasonographyDIAGNOSTIC_TEST

Lung ultrasound scan during preoperative anaesthesia consultation

Lung ultrasonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing elective general surgery;
  • age \>18 years;
  • ability to provide written consent;
  • use of Chest radiography during the preoperative evaluation.

You may not qualify if:

  • age \< than 18 year;
  • pregnant patients;
  • not use of Chest radiography during the preoperative evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pisa

Pisa, Italy

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

April 2, 2017

First Posted

April 13, 2017

Study Start

June 18, 2017

Primary Completion

August 1, 2017

Study Completion

September 28, 2017

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations