Airway Management in Thoracic Anesthesia in Italy (AIRTHOR)

March 25, 2018 updated by: Giorgio Della Rocca, Azienda Ospedaliera S. Maria della Misericordia

Airway Management in Thoracic Surgery and Incidence Rate of Dislocation and Related Intraoperative Hypoxemia: State of the Art in Italy

The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

A prospective randomized trial was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons.

Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked.

Data were analyzed with Student't Test and Chi-square test; p value < 0.05 was considered to be significant.

Study Type

Observational

Enrollment (Actual)

2129

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
    • Udine/Italy
      • Udine, Udine/Italy, Italy, 33100
        • Department of Anesthesia and Intensive Care

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing thoracic surgery

Description

Inclusion Criteria:

  • patients who need one lung ventilation undergoing thoracic surgery

Exclusion Criteria:

  • age < 18 years old

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
Intervention / Treatment
DLT versus bronchial blockers
double lumen tube versus bronchial blockers
Device: DLT versus bronchial blockers
Safety and efficacy of the double-lumen tubes (DLT) and bronchial blockers (BB) for lung isolation in patients undergoing thoracic surgery have been extensively studied and most of the results show similar rates of successful placement and lung collapse. DLT and BB are more frequently inserted by anesthetists who are expert in thoracic anesthesia, with dedicated but different training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS.
Time Frame: 11/19/2012

A prospective randomized trial was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons.

Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked.

Data were analyzed with Student't Test and Chi-square test; p value < 0.05 was considered to be significant.
11/19/2012

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera S. Maria della Misericordia

Investigators

  • Principal Investigator: Giorgio Della Rocca, prof, AOU Santa Maria della Misericordia

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

Helpful Links

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

July 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

February 7, 2015

First Posted (ESTIMATE)

February 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 25, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • AirwaysThor
  • Local ethics committee ALI01 (OTHER: AOU Santa Maria della Misericordia)

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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