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CompletedNCT02361983AIRTHORUpdated Oct 1, 2025

Airway Management in Thoracic Anesthesia in Italy

An observational study in Mechanical Ventilation Complication, sponsored by Azienda Ospedaliera S. Maria della Misericordia. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by Azienda Ospedaliera S. Maria della Misericordia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,225
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Mechanical Ventilation Complication
03

In context

Lead sponsor

Azienda Ospedaliera S. Maria della Misericordia is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing thoracic surgery

Inclusion criteria

  • patients who need one lung ventilation undergoing thoracic surgery

Exclusion criteria

Exclusion Criteria:

  • age \< 18 years old
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,225 participants (actual)
Patient registry
No

Groups and cohorts

  • DLT

    Patients managed with a Double lumen tube (DLT)

    Device: Double lumen tube

  • Bronchial blockers

    Patients managed with a Bronchial blocker (BB)

    Device: Bronchial blocker

Interventions

  • DeviceDouble lumen tube

    Patients managed with a double lumen tube for one lung ventilation

    Also known as: DLT

  • DeviceBronchial blocker

    Patients managed with a bronchial blocker for one lung ventilation

    Also known as: BB

06

What researchers measure

Primary outcomes

  1. DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS.

    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.

    Time frame: 11/19/2012

07

Study locations

1 site
  • Department of Anesthesia and Intensive Care
    Udine, Udine/Italy 33100, Italy
08

References and documents

Publications

  • Narayanaswamy M, McRae K, Slinger P, Dugas G, Kanellakos GW, Roscoe A, Lacroix M. Choosing a lung isolation device for thoracic surgery: a randomized trial of three bronchial blockers versus double-lumen tubes. Anesth Analg. 2009 Apr;108(4):1097-101. doi: 10.1213/ane.0b013e3181999339. PubMed 19299767 ↗
  • Campos JH, Hallam EA, Ueda K. Training in placement of the left-sided double-lumen tube among non-thoracic anaesthesiologists: intubation model simulator versus computer-based digital video disc, a randomised controlled trial. Eur J Anaesthesiol. 2011 Mar;28(3):169-74. doi: 10.1097/EJA.0b013e328340c332. PubMed 21088594 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02361983
Lead sponsor
Azienda Ospedaliera S. Maria della Misericordia
Responsible party
Giorgio Della Rocca (Professor and Chair of Anesthesia and Intensive Care Medicine Medical School of the University of Udine University of Udine. Udine, Italy, Azienda Ospedaliera S. Maria della Misericordia) — Principal investigator
First posted
Feb 12, 2015
Start date
Jul 2012
Primary completion
Nov 2013
Completion
Dec 2014
Last update
Oct 1, 2025

Study contacts

Giorgio Della Rocca, prof
principal investigator · AOU Santa maria della Misericordia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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