Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy
1 other identifier
interventional
49
1 country
1
Brief Summary
Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards the larynx around the steep blade angulation despite adequate visualization of the glottis. Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators hypothesized that using articulating stylet (AS) would enhance first attempt intubation, shorten the intubation time, reduce the possibility of the soft tissue trauma compared to conventional intubation stylet (IS) in patients with difficult airway .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedApril 3, 2018
April 1, 2018
1.7 years
June 13, 2016
April 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intibation time
Total intubation time (second)
Through intubation completion, an avarage of 5 minutes
Secondary Outcomes (1)
tracheal intubation attempts
Through intubation completion, an avarage of 5 minutes
Study Arms (2)
Group A
ACTIVE COMPARATORarticulating stylet
group C
ACTIVE COMPARATORconventional stylet
Interventions
Eligibility Criteria
You may qualify if:
- ASA 1-2 physical status (Anticipated difficult airway) ADA scores \>6 Elective surgery
You may not qualify if:
- ASA 3-4 physical status Immobilizedcervical spine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Ankara, 06110, Turkey (Türkiye)
Related Publications (2)
Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PMID: 9416711RESULTSuppan L, Tramer MR, Niquille M, Grosgurin O, Marti C. Alternative intubation techniques vs Macintosh laryngoscopy in patients with cervical spine immobilization: systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2016 Jan;116(1):27-36. doi: 10.1093/bja/aev205. Epub 2015 Jun 30.
PMID: 26133898RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Derya Özkan, MD
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated profesor
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 20, 2016
Study Start
June 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
April 3, 2018
Record last verified: 2018-04