Airway Management in Thoracic Anesthesia in Italy

NCT ID: NCT02361983

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

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Mechanical Ventilation Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DLT

Patients managed with a Double lumen tube (DLT)

Double lumen tube

Intervention Type DEVICE

Patients managed with a double lumen tube for one lung ventilation

Bronchial blockers

Patients managed with a Bronchial blocker (BB)

Bronchial blocker

Intervention Type DEVICE

Patients managed with a bronchial blocker for one lung ventilation

Interventions

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Double lumen tube

Patients managed with a double lumen tube for one lung ventilation

Intervention Type DEVICE

Bronchial blocker

Patients managed with a bronchial blocker for one lung ventilation

Intervention Type DEVICE

Other Intervention Names

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DLT BB

Eligibility Criteria

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Inclusion Criteria

* patients who need one lung ventilation undergoing thoracic surgery

Exclusion Criteria

* age \< 18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera S. Maria della Misericordia

OTHER

Sponsor Role lead

Responsible Party

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Giorgio Della Rocca

Professor and Chair of Anesthesia and Intensive Care Medicine Medical School of the University of Udine University of Udine. Udine, Italy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giorgio Della Rocca, prof

Role: PRINCIPAL_INVESTIGATOR

AOU Santa maria della Misericordia

Locations

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Department of Anesthesia and Intensive Care

Udine, Udine/Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 19299767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21088594 (View on PubMed)

Other Identifiers

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Local ethics committee ALI01

Identifier Type: OTHER

Identifier Source: secondary_id

AirwaysThor

Identifier Type: -

Identifier Source: org_study_id

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