Airway Management in Thoracic Anesthesia in Italy

NCT02361983 | Completed DMC

• 2 other identifiers: AirwaysThorLocal ethics committee ALI01
• Study Type: observational
• Target: 2,225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mechanical Ventilation Complication

Outcome Measures

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.

  11/19/2012

Study Arms (2)

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

Double lumen tube DEVICE

Patients managed with a double lumen tube for one lung ventilation

Also known as: DLT

DLT

Bronchial blocker DEVICE

Patients managed with a bronchial blocker for one lung ventilation

Also known as: BB

Bronchial blockers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing thoracic surgery

You may qualify if:

• patients who need one lung ventilation undergoing thoracic surgery

You may not qualify if:

• age \< 18 years old

Sponsors & Collaborators

• Azienda Ospedaliera S. Maria della Misericordia: lead

Study Sites (1)

Department of Anesthesia and Intensive Care

Udine, Udine/Italy, 33100, Italy

Location

Related Publications (2)

• 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.

  PMID: 19299767 BACKGROUND

• 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.

  PMID: 21088594 BACKGROUND

Study Officials

• Giorgio Della Rocca, prof

  AOU Santa maria della Misericordia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Anesthesia and Intensive Care Medicine Medical School of the University of Udine University of Udine. Udine, Italy

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: February 12, 2015
• Study Start: July 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

IT (1)