Clinical Trials Directory

Trials / Completed

CompletedNCT02361983

Airway Management in Thoracic Anesthesia in Italy

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

Status
Completed
Phase
Study type
Observational
Enrollment
2,225 (actual)
Sponsor
Azienda Ospedaliera S. Maria della Misericordia · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEDouble lumen tubePatients managed with a double lumen tube for one lung ventilation
DEVICEBronchial blockerPatients managed with a bronchial blocker for one lung ventilation

Timeline

Start date
2012-07-01
Primary completion
2013-11-01
Completion
2014-12-01
First posted
2015-02-12
Last updated
2025-10-01

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02361983. Inclusion in this directory is not an endorsement.