NCT02571621

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
745

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1989

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1989

Completed
17.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

17.4 years

First QC Date

October 1, 2015

Last Update Submit

October 20, 2023

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Success rate

    Measurement time in seconds using a stopwatch between grasping the tube and successful intubation

    3 minutes

Secondary Outcomes (3)

  • BMI

    1hour

  • method of insertion and size of the tube,

    1hour

  • Intubator's qualification and experience in the use of the ETC;

    1 hour

Study Arms (1)

Patients intubated with Combitube

Patients with Combitube intubation undergoing general anesthesia with ASA class I and II

Device: Combitube

Interventions

CombitubeDEVICE

Intubation with Combitube

Patients intubated with Combitube

Eligibility Criteria

Age18 Years - 100 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing general anesthesia physical status ASA class I and II

You may qualify if:

  • patients ASA class I and II

You may not qualify if:

  • patients not able to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med. Univ. Vienna, Dept. Internal Med. I

Vienna, A1090, Austria

Location

Related 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.

    PMID: 25425779RESULT

Study Officials

  • Michael Frass, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Medical Doctor

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 8, 2015

Study Start

January 1, 1989

Primary Completion

June 1, 2006

Study Completion

December 1, 2006

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

AU(1)