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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03516539
Other study ID # 2017-I043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 11, 2017
Est. completion date July 7, 2018

Study information

Verified date April 2018
Source Hallym University Medical Center
Contact Yi Hwa Choi, Dr.
Phone 82-31-380-3813
Email pcyhchoi@hallym.or.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed, portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved blade.

Mcgrath is known to provide excellent laryngeal visibility even in case of anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway management. However, compared with direct laryngoscopy, the success rate of intubation and the time required for anticipated difficult intubation have been reported conflicting results in previous studies. The aim of this study was to compare the intubation success rate, the intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy during intubation.


Description:

1. In the operating room, all patients are monitored with an electrocardiograph, noninvasive blood pressure, pulse oximeter, capnograph and Bispectral index (BIS) monitor. After pre-oxygenation with 100% oxygen for 1 minute, intravenous anesthesia (TIVA) with propofol and remifentanyl is administrated and followed by rocuronium (0.6mg/kg). When patients are lost their consciousness, manual mask ventilation is proceeded with 100% oxygen for 2 minutes.

2. Transoral endotracheal intubation is performed using Mcgrath videolaryngoscope (Group ML) and direct laryngoscope (Group DL) using manual in-line stabilization. At this time, the time required for intubation is measure by other medical personnel not engaged in this research.

3. The anesthesiologist assesses Cormack Lehane laryngeal visual field,external laryngeal manipulation, intubation difficulty scales (IDS) and the difficulty of intubation.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 7, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients scheduled for general anesthesia requiring tracheal intubation. Patients are aged 19 to 70 years and are American Society of Anesthesiologists physical status I, II.

Exclusion Criteria:

- Patients requiring rapid sequence intubation Patients with poor teeth or high risk of aspiration pneumonia Cervical spine pathology, pharyngeal pathology

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Group ML
Mcgrath videolaryngoscope
Group DL
Macintosh laryngoscope

Locations

Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Asai T, Murao K, Shingu K. Training method of applying pressure on the neck for laryngoscopy: use of a videolaryngoscope. Anaesthesia. 2003 Jun;58(6):602-3. — View Citation

Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. — View Citation

Shippey B, Ray D, McKeown D. Case series: the McGrath videolaryngoscope--an initial clinical evaluation. Can J Anaesth. 2007 Apr;54(4):307-13. — View Citation

Shippey B, Ray D, McKeown D. Use of the McGrath videolaryngoscope in the management of difficult and failed tracheal intubation. Br J Anaesth. 2008 Jan;100(1):116-9. Epub 2007 Oct 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intubation success rate success or failure of intubation 1 hour
Secondary Time required for intubation time until end tidal carbon dioxide (CO2) measurement after laryngeal blade passing through patient's teeth 1 hour
Secondary Intubation difficulty score difficulty at the time of intubation. (easy /moderate/ difficult) 1 hour
Secondary Complications oral bleeding, teeth or lip bleeding 1 day
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