Laryngoscope-assisted Lightwand Intubation and Cervical Spine Motion

NCT02430415 | Unknown DMC

• 1 other identifier: LALI
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

• maximum cervical spine motion

  maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments.

  during tracheal intubation

Secondary Outcomes (3)

• intubation time

  during tracheal intubation

• number of intubation trial

  during tracheal intubation

• sore throat, pain score

  after extubation ~ postoperative day 1

Study Arms (2)

Group A

EXPERIMENTAL

laryngoscope-assisted lightwand intubation - traditional lightwand intubation

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

Group B

EXPERIMENTAL

traditional lightwand intubation - laryngoscope-assisted lightwand intubation

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

Interventions

laryngoscope-assisted lightwand intubation DEVICE

laryngoscope-assisted lightwand intubation

Group A; Group B

traditional lightwand intubation DEVICE

traditional lightwand intubation

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (3)

• 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):910-915. doi: 10.1213/01.ane.0000166975.38649.27.

  PMID: 16116013 BACKGROUND

• Davis L, Cook-Sather SD, Schreiner MS. Lighted stylet tracheal intubation: a review. Anesth Analg. 2000 Mar;90(3):745-56. doi: 10.1097/00000539-200003000-00044. No abstract available.

  PMID: 10702469 BACKGROUND

• Kim TK, Son JD, Seo H, Lee YS, Bae J, Park HP. A Randomized Crossover Study Comparing Cervical Spine Motion During Intubation Between Two Lightwand Intubation Techniques in Patients With Simulated Cervical Immobilization: Laryngoscope-Assisted Versus Conventional Lightwand Intubation. Anesth Analg. 2017 Aug;125(2):485-490. doi: 10.1213/ANE.0000000000001813.

  PMID: 28244946 DERIVED

Study Officials

• Hee Pyung Park, MD PhD

  Seoul National University of Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Pyung Park, MD PhD

CONTACT

82-2-2072-2466; hppark@snu.ac.kr

Tae Kyong Kim, MD

CONTACT

82-2- 2072-2469; ktkktk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 30, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 30, 2015

Record last verified: 2015-04