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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02969889
Other study ID # KOU KAEK 2014/137
Secondary ID
Status Completed
Phase N/A
First received November 18, 2016
Last updated February 2, 2017
Start date June 2016
Est. completion date November 2016

Study information

Verified date February 2017
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.


Description:

80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial.

Divided into two groups ; Airtraq and ILMA .

BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this study.

patients demographic and airway variables were recoded. Patients were premedicated. After standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium was used for neuromuscular blockade.

The device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:18-65 years of age

- ASA I-III

- BMI>35

Exclusion Criteria:BMI<35

- patients have airway tumor

- patients undergoing head and neck surgery

- upper respiratory infection less than 10 days prior the surgery

Study Design


Intervention

Device:
Airtraq
video laryngoscope with a channel
ILMA


Locations

Country Name City State
Turkey Kocaeli University School of Medicine Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary intubation time handling of the device till the endotracheal tube entering the glottis 1 minute
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