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Clinical Trials/NCT02361983
NCT02361983CompletedNot Applicable

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

Azienda Ospedaliera S. Maria della Misericordia1 site in 1 country2,225 target enrollmentStarted: July 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2,225
Locations
1
Primary Endpoint
DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS.

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients who need one lung ventilation undergoing thoracic surgery

Exclusion Criteria

  • age < 18 years old

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Azienda Ospedaliera S. Maria della Misericordia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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