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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01215695
First received: July 22, 2010
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Difficult Endotracheal Intubation
Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)
Device: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Intubation time [ Time Frame: During intubation ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The number of intubation attempts [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    counted as each approach of the ETT to the glottic entrance.

  • Neck Movement: [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement

  • laryngeal view grade [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The laryngeal view grade according to the method described by Cormack and Lehane

  • Ease of intubation [ Time Frame: 2-4 hours after intubation ] [ Designated as safety issue: No ]
    After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.


Estimated Enrollment: 140
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
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
pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
Experimental: Intervention
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)
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.
Other Name: video-stylet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Full stomach
  • Hiatal hernia
  • Severe GERD (Gastroesophageal reflux disease)
  • Tumors of the upper airway
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215695

Contacts
Contact: Rainer Lenhardt, MD 502-852-3122 rainer.lenhardt@louisville.edu

Locations
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ozan Akca, m    502-852-1739    ozan.akca@louisville.edu   
Principal Investigator: Rainer Lenhardt, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Rainer Lenhardt, MD University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01215695     History of Changes
Other Study ID Numbers: UofL IRB #10.0300
Study First Received: July 22, 2010
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Intubation, Endotracheal
Endotracheal Intubation, adverse events

ClinicalTrials.gov processed this record on August 28, 2014