NCT01917565

Brief Summary

The investigators hypothesize that when used by experienced anesthesiologists, Airtraq laryngoscope will increase the first-attempt success rate with shorter intubation times and more stable hemodynamic parameters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

6 months

First QC Date

August 2, 2013

Last Update Submit

August 5, 2013

Conditions

the Hemodynamic ParametersIntubation TimesComplications During and After Intubation

Keywords

airway managementlaryngoscopeAirtraqMacintosh laryngoscopefiberoptic bronchoscopeintubation

Outcome Measures

Primary Outcomes (1)

  • The required time to successful tracheal intubation

    The primary outcome variable is the required time to successful tracheal intubation

    six months

Secondary Outcomes (1)

  • The first-attempt success rate of tracheal intubation

    six months

Other Outcomes (1)

  • the effects of the tracheal intubation on hemodynamic parameters

    six months

Study Arms (3)

Airtraq laryngoscope group

The patients who will be intubated by using Airtraq laryngoscope

Macintosh laryngoscope group

The patients who will be intubated by using Macintosh laryngoscope

Fiberoptic bronchoscope group

The patients who will be intubated by using Fiberoptic bronchoscope

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing surgery under general anesthesia

You may qualify if:

  • ASA physical status classification of 1 or 2, undergoing elective surgery under general anesthesia and requiring endotracheal intubation

You may not qualify if:

  • Patients with ASA 3 or 4, Mallampati score of 3 or 4, history of difficult intubation, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, body mass index higher than 35 kg/m2 and limited neck mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Marmara University School of Medicine

Istanbul, 34734, Turkey (Türkiye)

Location

Central Study Contacts

Kemal T Saracoglu, Assist. Prof. M.D.

CONTACT

+902166570606saracoglukt@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 6, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

August 6, 2013

Record last verified: 2013-08

Locations

TU(1)