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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03685968
Other study ID # HSC-MS-13-0024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2013
Est. completion date December 17, 2015

Study information

Verified date January 2019
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are several advantages of video laryngoscopy; especially their ability to provide superior glottis visualization, as compared to traditional laryngoscopy.1-3 The purpose of this three arm study was to compare the safety and efficacy of the King Vision® Video Intubation Systems (AMBU-King Systems, Denmark) to the Cobalt GlideScope® (Verathon Medical Inc., USA) in patients with anticipated difficult airways.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date December 17, 2015
Est. primary completion date November 17, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Over 18 years of age

- Mallampati III-IV

- Neck circumference > 43cm

- Reduced mouth opening (< 4cm) or 3 Finger breath's (patient's own)

- Thyromental distance < 6cm

Exclusion Criteria:

- Mallampati I-II

- Neck circumference < 43cm

- Documented 'easy' intubation

- Previous history of failed intubation and failed bag-mask ventilation

- Under 18 years of age

- ASA IV

- Known unstable cervical spine injury

- Presentation for an emergency surgical procedure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Video laryngoscopes
Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston King Systems Corporation

References & Publications (3)

Hagberg C, Matuszczak M, Ellis S, et al. A randomized comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in obese patients. Anesthesiology 2005; 103: A1420.

Hagberg C, Vogt-Harenkamp C, Bogomolny Y, et al. A comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in potentially difficult to intubate patients. Anesth Analg 2005; 100: S-212.

Hagberg CA, Iannucci D, Goodrich A. A comparison of the glottic view obtained with the Macintosh Video Laryngoscope in anesthetized, paralyzed, apneic patients. Direct view vs video monitor. Anesthesiology 2003; 103: A1501.

Outcome

Type Measure Description Time frame Safety issue
Other Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL Total time for placing the endotracheal tube (ETT) through the vocal cords During laryngoscopy and endotracheal tube placement
Primary Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL During laryngoscopy and endotracheal tube placement
Secondary First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL During laryngoscopy and endotracheal tube placement
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