Video-laryngoscope With a Novel Video-stylet for Difficult Intubation

NCT01215695 | Completed Results

• 1 other identifier: UofL IRB #10.0300
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).

Conditions

Difficult Endotracheal Intubation

Keywords

Intubation, Endotracheal; Endotracheal Intubation, adverse events

Outcome Measures

Primary Outcomes (1)

• Intubation Time

  divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.

  120 seconds

Secondary Outcomes (4)

• The Number of Intubation Attempts

  30 minutes

• Neck Movement

  30 minutes

• Laryngeal View Grade of 1 or 2

  30 minutes

• Ease of Intubation

  2-4 hours after intubation

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Device: Control

Intervention

EXPERIMENTAL

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)

Interventions

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) DEVICE

The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Also known as: video-stylet

Intervention

Control DEVICE

pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 35
• Thyromental distance \< 6 cm
• Sterno-mental distance \< 12 cm
• Mallampati grade 3 and 4
• Interincisor distance \< 38 mm
• Status of dentition: presence of buckteeth
• Neck movement \< 35°
• Neck circumference \>43 cm at the level of the thyroid cartilage
• Patients with immobilized cervical spine (C-collar in place).
• History of difficult laryngoscopy or intubation

You may not qualify if:

• Full stomach
• Hiatal hernia
• Severe GERD (Gastroesophageal reflux disease)
• Tumors of the upper airway

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.

  PMID: 24842175 RESULT

Results Point of Contact

• Title: Rainer Lenhardt, MD
• Organization: University Louisville

rainer.lenhardt@louisville.edu

502-228-7517

Study Officials

• Rainer Lenhardt, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: October 6, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 8, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-08

Locations

US (1)