Airway Management in Thoracic Anesthesia in Italy

Completed

• Conditions: Mechanical Ventilation Complication

• Registration Number: NCT02361983
• Lead Sponsor: Azienda Ospedaliera S. Maria della Misericordia

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.

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 Timeline

• Study Start: 2012-07-01
• Study First Submitted: 2012-12-03
• Primary Completion: 2013-11
• Study Completion: 2014-12-01
• Study First Submitted QC: 2015-02-07
• Study First Posted: 2015-02-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2225

Inclusion Criteria

• patients who need one lung ventilation undergoing thoracic surgery

Exclusion Criteria

• age < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS.	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.

Trial Locations

Locations (1)

Department of Anesthesia and Intensive Care; 🇮🇹 Udine, Udine/Italy, Italy