Tracheal Intubation With Collar Immobilisation : a Comparison of Glidescope and Fastrach

Injury of Cervical Spine Clinical Trial

Official title:

A Comparison of Glidescope and ILMA in Simulated Sercial Spine Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245880
• Other study ID #: KOÜ KAEK 2013/33
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2014
• Last updated: March 31, 2015
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients undergoing elective surgery were enrolled in this trial. After standard monitorisation including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were divided into two groups glidescope and fastrach. Rigid collar was placed then patients were intubated with one of these devices. Mask ventilations with or without collar were recorded. insertion times, intubation times of the devices were recorded. Peroperative hemodynamic parameters and postoperative minor complications were also recoded.

Description:

inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring intubation exclusion criteria:

• pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years of age

• ASA I-II

• requiring intubation

• BMI<35

Exclusion Criteria:

• less than 18 or higher than 65

• ASA III-IV

• BMI> 35

• PREGNANT

• head and neck tumors

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Injury of Cervical Spine

Intervention

Device:
• Glidescope
videolaryngoscope
• ILMA
handling of the device till the optimal ventilation achieved

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
Other	minor complications		From the end of surgery till 2 hours postoperatively	Yes
Other	Mucosal damage		Bloodstain on the device after removal	Yes
Primary	intubation times		From handling of the device till intibation	Yes
Secondary	Heart rate		From Preoperative heart rate till 15 minutes After intubation	Yes
Secondary	Mean arterial pressure		From preinduction till 15 minutes after intubation	Yes