Clinical trial NCT02805569: Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy
Official title: Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy in Patients With Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Keywords: videolaryngoscope
intubation stylet
articulating stylet
difficult airway
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .

Detailed description: Patients with known airway difficulty (anticipated difficult airway (ADA) score \>6) will be included to the study.

All patients will receive general anesthesia for a variety of elective surgical procedure. Tracheal intubation will be performed by senior anesthesiologist. Patients will be intubated using AS-videolaryngoscope (n= 24) or IS-videolaryngoscope (n=24) randomly. Patients demographic details (age 18-65 yr, body mass index, ASA phisical status), ADA scores, Cormack-Lehane scores, intubation difficulty scores, intubation attempts, intubation time, hemodynamic variables, sore throat, anesthesiologists satisfaction will be recorded.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2 physical status (Anticipated difficult airway) ADA scores \>6 Elective surgery

Exclusion Criteria:

* ASA 3-4 physical status Immobilizedcervical spine

Primary outcomes:
measure: intibation time
timeFrame: Through intubation completion, an avarage of 5 minutes
Secondary outcomes:
measure: tracheal intubation attempts
timeFrame: Through intubation completion, an avarage of 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Study officials:
affiliation: Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
name: Derya Özkan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Suppan 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.