Serial Usage of Combitube in Anesthesiology | NCT02571621

Studies
Serial Usage of Combitube in Anesthesiology

NCT02571621

Sponsor

Michael Frass

Status

Completed

Last Update Posted

Oct 24, 2023Actual

Enrollment

745Actual

Phase

Not provided

Conditions

Surgery

Interventions

Combitube

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1989

Primary Completion Date

Jun 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Oct 1, 2015

First Submission Date that Met QC Criteria

Oct 6, 2015

First Posted Date

Oct 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2023

Last Update Posted Date

Oct 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

745Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients intubated with Combitube		Patients with Combitube intubation undergoing general anesthesia with ASA class I and II	Device: Combitube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combitube	Device	Intubation with Combitube	Patients intubated with Combitube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate	Measurement time in seconds using a stopwatch between grasping the tube and successful intubation	3 minutes

Secondary Outcomes

Measure	Description	Time Frame
BMI	Measurement of Body mass index by calculating height and weight of each patient	1hour
method of insertion and size of the tube,	insertion with different intubation devices and diameters of tubes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients ASA class I and II

Exclusion Criteria:

patients not able to sign informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing general anesthesia physical status ASA class I and II

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Frass, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Med. Univ. Vienna, Dept. Internal Med. I		Vienna		A1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25425779	Result	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.