Videolaryngoscopes for Tracheal Intubation

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02897518
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®.

Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm, mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.

Condition or Disease	Intervention/Treatment	Phase
Airway Management	Device: Imago V-Balde; Device: Glidescope	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endotracheal intubation with Imago V-blade Patients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes.	Device: Imago V-Balde; the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual
Active Comparator: endotracheal intubation with Glidescope Patients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes.	Device: Glidescope; the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

Outcome Measures

Primary Outcome Measures

1. feasibility of endotracheal intubation [within 60 seconds]

Secondary Outcome Measures

1. Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope [wthin 120 seconds]

   Time to reach a successful endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

2. Intubation time [wthin 120 seconds]

   time to reach endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

3. Cormack and Lehane score view [During endotracheal intubation]

4. use of adjunctive maneuvers to aid the endotracheal intubation [During endotracheal intubation]

   the investigators evaluated the necessary maneuvers to aid a successful endotracheal intubation as number of Readjusting patient's head, number of external laryngeal pressure, number of advancement or withdrawal the blade and number of increased lifting force

5. Intubation difficulty scale score [within 60 seconds]

   Time to pass the vocal cord during the successful endotracheal intubation measured from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 77 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age>18 years

• Mallampati class 3-4

• inter-incisor distance < 30 mm

• mental-thyroidal distance < 60 mm

• large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility

• reduced mental-jugular distance.

Exclusion Criteria:

• < 1 criteria for predicted difficult airway

• emergency surgery

• age < 18 years

• declined consent to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Naples Federico II department of Anesthesia and Critical Care	Naples		Italy	80100

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Vargas, MD, Federico II University
• ClinicalTrials.gov Identifier: NCT02897518
• Other Study ID Numbers: Airway1
• First Posted: Sep 13, 2016
• Last Update Posted: Jan 5, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Maria Vargas, MD, Federico II University: Videolaryngoscopes; Intubation

Study Results

No Results Posted as of Jan 5, 2017