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

NCT ID: NCT02245880

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-09-30

Brief 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.

Detailed 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

Conditions

Injury of Cervical Spine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Glidescope videolaryngoscope

cervical collar was applied to 47 patients then facemask ventilations were recoded intubated with Glidescope and insertion time: handling of the device till the good glottic visualisation intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device after removal heart rate preinduction heart rate postinduction heart rate postinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation wrere recorded. postoperative minor complications were recorded.

Group Type: ACTIVE_COMPARATOR

Glidescope

Intervention Type: DEVICE

videolaryngoscope

Intubating laryngeal mask airway

cervical collar was applied to 47 patients then facemask ventilations through the collar were recorded and intubated with ILMA insertion time: handling of the device till the good glottic visualisation appears intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device heart rate preinduction heart rate postinduction heart rate posinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation

Group Type: ACTIVE_COMPARATOR

ILMA

Intervention Type: DEVICE

handling of the device till the optimal ventilation achieved

Interventions

Glidescope

videolaryngoscope

Intervention Type: DEVICE

ILMA

handling of the device till the optimal ventilation achieved

Intervention Type: DEVICE

Other Intervention Names

FASTRACH

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Zehra Ipek ARSLAN

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zehra I ARSLAN, Specialist

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Reanimation

Locations

Kocaeli University School of Medicine

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOÜ KAEK 2013/33

Identifier Type: -

Identifier Source: org_study_id