Shunt Evaluation With ALPE System in Thoracic Surgery

March 29, 2017 updated by: Savino Spadaro, Università degli Studi di Ferrara
. The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (OLV) at different levels of positive end expiratory pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during OLV.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

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

  • Italy
      • Ferrara, Italy, 44121
        • Azienda Ospedaliero Universitaria Sant'Anna

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

Sampling Method

Probability Sample

Study Population

Patients undergoing thoracoscopic surgery

Description

Inclusion Criteria:

  • patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus.
  • patients American Society of Anesthesiologists Physical Status Classification score of 1-3

Exclusion Criteria:

  • Patients with hemodynamic instability,
  • Patients with severe chronic respiratory failure
  • Patients with preoperative anemia (hemoglobin <10 g 100 ml-1)
  • Patients requiring unplanned conversion to thoracotomy

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

Cohorts and Interventions

Group / Cohort
Low shunt group
patients with shunt less than 30% in one-lung ventilation at ZEEP
High shunt group
Patients with shunt equal or more than 30% in one-lung ventilation at ZEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary shunt evaluated with ALPE system
Time Frame: every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes
every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictors of high intraoperative shunt
Time Frame: The outcome is assessed 15 minutes after one lung ventilation
All patients admitted to the study received a preoperative physiologic assessment with a cardiovascular evaluation and spirometry. After 15 minutes of one lung ventilation, the pulmonary shunt is evaluated. Therefore, all clinical variable evaluated during preoperative assessment will be compared with the pulmonary shunt
The outcome is assessed 15 minutes after one lung ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEAT

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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