Laryngoscope-assisted Lightwand Intubation and Cervical Spine Motion

Intubation; Difficult Clinical Trial

Official title:

A Randomized Trial on Comparison of Effects of Two Lightwand Intubation Techniques on Cervical Spine Motion: Laryngoscope-assisted vs. Conventional Lightwand Intubation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02430415
• Other study ID #: LALI
• Status: Not yet recruiting
• Phase: N/A
• First received: April 22, 2015
• Last updated: April 26, 2015
• Start date: May 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2015
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the effect of the laryngoscope-assisted lightwand intubation technique vs. the conventional lightwand intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.

Description:

In clinical practice, the investigators have occasionally experienced some difficulties in the lightwand intubation in patients with cervical spine instability because manual in-line stabilization during intubation hinders free movements of the lightwand such as advancement, withdrawal, and scooping in the oral cavity. For this reason, jaw thrust is often used to secure enough space for free movements of the lightwand in the oral cavity in the traditional lightwand intubation technique. A recent study showed that laryngoscope-assisted lightwand intubation provided more successful intubation on the first attempt and less scooping movement than the traditional lightwand intubation by facilitating free movements of the lightwand in the oral cavity in patients with cervical immobilization during intubation for cervical spine surgery. In the laryngoscope-assisted lightwand intubation technique, the direct laryngoscope may provide sufficient space for free movements of the lightwand in the oral cavity without jaw thrust, which can result in cervical spine movement. However, the effect of the laryngoscope-assisted lightwand intubation technique on cervical spine motion is not investigated yet.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: April 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with American Society of Anesthesiologists physical status of 1-2 and age of 18-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.

Exclusion Criteria:

• Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.

• Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.

• Body mass index > 30

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Device:
• laryngoscope-assisted lightwand intubation
laryngoscope-assisted lightwand intubation
• traditional lightwand intubation
traditional lightwand intubation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (2)

Davis L, Cook-Sather SD, Schreiner MS. Lighted stylet tracheal intubation: a review. Anesth Analg. 2000 Mar;90(3):745-56. Review. — View Citation

Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-5, table of contents. Erratum in: Anesth Analg. 2005 Oct;101(4):1011. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum cervical spine motion	maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments.	during tracheal intubation	No
Secondary	intubation time		during tracheal intubation	No
Secondary	number of intubation trial		during tracheal intubation	No
Secondary	sore throat, pain score		after extubation ~ postoperative day 1	Yes