Rigid Video Stylet Vs Conventional Lightwand Intubation

NCT02073786 | Unknown DMC

• 1 other identifier: Optiscope_SNUH
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. In many previous studies, rigid video stylet has proven advantages compared with other intubating devices.

Conditions

Hoarseness; Intubation; Sorethroat

Outcome Measures

Primary Outcomes (1)

• Primary success rate of intubation

  compare primary success rate of intubation using Optiscope with lightwand intubation

  within 90 sec from insertion of device

Secondary Outcomes (5)

• Intubation time

  within 90 seconds from insertion of device

• postoperative complications

  During PACU stay time expected up to 1hr

• postoperative complications

  24 hr after operation

• hemodynamic change

  baseline and 1minute after intubation

• number of intubation trial and scooping movements

  during intubation time, an expected average of 1minute

Study Arms (2)

Lightwand

ACTIVE COMPARATOR

Conventional lightwand intubation will performe for intubation

Device: Conventional lightwand intubation

Optiscope

EXPERIMENTAL

Rigid video stylet, manufactural named Optiscope, will perform for intubation

Device: Rigid video stylet

Interventions

Conventional lightwand intubation DEVICE

Conventional lightwand intubation technique will perform during intubation

Lightwand

Rigid video stylet DEVICE

Rigid video stylet will inserted through endotracheal tube before induction. After induction with propofol and remifentanil using TIVA infusion pump, rocuronium 0.6mg/kg were used to facilitate intubation. After 2minutes, board-certificated anesthesiologist perform intubation using Optiscope.

Also known as: Optiscope® (Pacific Medical, Seoul, Republic of Korea)

Optiscope

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for cervical spine surgery under general anesthesia
• aged between 20- 80 yrs

You may not qualify if:

• Patient who disagrees to participate this study
• Patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
• Patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University of Hospital

Seoul, 110-799, South Korea

RECRUITING

MeSH Terms

Conditions

Hoarseness

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Hee Pyung Park, MD PhD

  Professor

  STUDY DIRECTOR

• Eugene Kim, MD

  fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Pyung Park, MD PhD

CONTACT

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

Eugene Kim, MD

CONTACT

82-2-2072-2469; tomomie@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 27, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: February 18, 2015

Record last verified: 2014-02

Locations

KR (1)