Airway Management in Thoracic Anesthesia in Italy (AIRTHOR)

September 30, 2025 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 evaluate the positioning time and the malpositioning rate of DLTs and BBs, the degree of difficulty perceived in device positioning, the use of bronchoscopy (BRO), and the quality of lung collapse achieved during ONE LUNG VENTILATION.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The first objective of this study was to evaluate the positioning time and the malpositioning rate of DLTs and BBs, the degree of difficulty perceived in device positioning, the use of bronchoscopy (BRO), and the quality of lung collapse achieved during OLV.

A prospective observational study 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)

2225

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

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
Patients managed with a Double lumen tube (DLT)
Device: Double lumen tube
Patients managed with a double lumen tube for one lung ventilation
Other Names:
  • DLT
Bronchial blockers
Patients managed with a Bronchial blocker (BB)
Device: Bronchial blocker
Patients managed with a bronchial blocker for one lung ventilation
Other Names:
  • BB

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 (Estimated)

February 12, 2015

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • AirwaysThor
  • Local ethics committee ALI01 (Other Identifier: 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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