Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy

Difficult Intubation Clinical Trial

Official title:

Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy in Patients With Difficult Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805569
• Other study ID #: 27/28
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: April 1, 2018
• Start date: June 2016
• Est. completion date: February 2018

Study information

• Verified date: April 2018
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• ASA 3-4 physical status Immobilizedcervical spine

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• articulating stylet
patient who intubated with articulating stylet
• conventional stylet
patient who intubated with conventional stylet

Locations

Country	Name	City	State
Turkey	Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital Ankara, Turkey	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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 — View Citation

Suppan L, Tramèr 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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intibation time	Total intubation time (second)	Through intubation completion, an avarage of 5 minutes
Secondary	tracheal intubation attempts	number of intubation attempts	Through intubation completion, an avarage of 5 minutes