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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01917565
Other study ID # 09.2011.0127
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 2, 2013
Last updated August 5, 2013
Start date August 2013
Est. completion date March 2014

Study information

Verified date August 2013
Source Marmara University
Contact Kemal T Saracoglu, Assist. Prof. M.D.
Phone +902166570606
Email saracoglukt@gmail.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial 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.


Description:

The special design of the Airtraq allows the direct exposure of the glottic opening without the necessity of optimal alignment of the oral, pharyngeal and laryngeal axes. The results of the meta-analysis comparing the Airtraq with the conventional Macintosh laryngoscope concluded that the use of Airtraq results in a rapid and accurate intubation. The main advantages of the fiberoptic bronchoscope are minimal airway trauma and minimal deterioration of the hemodynamic parameters.

The purpose of this study is to compare the hemodynamic parameters, intubation times, complications during and after intubation and postoperative sore throat scores of the patients having normal airway anatomy, intubated with Airtraq, Macintosh laryngoscope or fiberoptic bronchoscope, by experienced anesthesiologists.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Department of Anesthesiology, Marmara University School of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other the effects of the tracheal intubation on hemodynamic parameters The other outcome variable is the effects of the tracheal intubation on hemodynamic parameters six months Yes
Primary The required time to successful tracheal intubation The primary outcome variable is the required time to successful tracheal intubation six months Yes
Secondary The first-attempt success rate of tracheal intubation The secondary outcome variable is the first-attempt success rate of tracheal intubation six months Yes
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