Serial Usage of Combitube in Anesthesiology

Surgery Clinical Trial

— Combitube  

Official title:

Evaluation of Serial Usage of Combitube in Anesthesiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571621
• Other study ID #: 2015/10
• Status: Completed
• Start date: January 1989
• Est. completion date: December 2006

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Description:

Background: The oesophageal-tracheal Combitube (ETC) was designed for the use in the pre-hospital setting and has proven its value both there and in difficult airway management. The ETC is a double-lumen tube and as such it enables ventilation independent of its position in either the trachea or the oesophagus. Since laryngoscopy is not necessary for positioning the ETC, it is especially favoured in pre-hospital setting, but is also used in clinical setting.

Objectives: Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 745
• Est. completion date: December 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• patients ASA class I and II

Exclusion Criteria:

• patients not able to sign informed consent

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Combitube
Intubation with Combitube

Locations

Country	Name	City	State
Austria	Med. Univ. Vienna, Dept. Internal Med. I	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Michael Frass

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Sethi AK, Desai M, Tyagi A, Kumar S. Comparison of combitube, easy tube and tracheal tube for general anesthesia. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):526-32. doi: 10.4103/0970-9185.142849. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Measurement time in seconds using a stopwatch between grasping the tube and successful intubation	3 minutes
Secondary	BMI	Measurement of Body mass index by calculating height and weight of each patient	1hour
Secondary	method of insertion and size of the tube,	insertion with different intubation devices and diameters of tubes	1hour
Secondary	Intubator's qualification and experience in the use of the ETC;	years of training and experience in intubators as well as use of ETC for at least 10 times	1 hour