Airway Management in Thoracic Anesthesia in Italy

Mechanical Ventilation Complication Clinical Trial

— AIRTHOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361983
• Other study ID #: AirwaysThor
• Secondary ID: Local ethics com
• Status: Completed
• First received: December 3, 2012
• Last updated: March 25, 2018
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2018
• Source: Azienda Ospedaliera S. Maria della Misericordia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

Description:

The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2129
• Est. completion date: December 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients who need one lung ventilation undergoing thoracic surgery

Exclusion Criteria:

• age < 18 years old

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• DLT versus bronchial blockers
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.

Locations

Country	Name	City	State
Italy	Department of Anesthesia and Intensive Care	Udine	Udine/Italy

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera S. Maria della Misericordia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View Citation

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   web site about evidence based medicine anaesthesia