Comparison of the Videolaryngoscopes With Manual In-line Stabilization

Oral Surgery Clinical Trial

Official title:

Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647606
• Other study ID #: AJIRB-MED-DE1-15-334
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: November 2018
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

• oral or maxillofacial surgery

• ASA class I, II

Exclusion Criteria:

• anticipated difficult intubation

• necessity for rapid sequence induction

• cervical spine injury

• bleeding tendency

Related Conditions & MeSH terms

• Maxillofacial Surgery
• Oral Surgery

Intervention

Procedure:
• MILS
MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.

Device:
• McGrath videolaryngoscope
McGrath videolaryngoscope will be used for intubation
• Pentax AWS videolaryngoscope
Pentax AWS videolaryngoscope will be used for intubation
• Macintosh laryngoscope
Macintosh laryngoscope will be used for intubation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for intubation		from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds
Primary	Cormack Lehane Laryngeal view		when laryngoscope is appropriately placed during intubation, approximately 2 seconds
Primary	POGP score	Percentage of glottic opening(POGO)	when laryngoscope is appropriately placed during intubation, approximately 2 seconds
Secondary	external laryngeal manipulation	When the laryngeal view is insufficient during laryngoscope, another physician can manipulate the larynx externally to improve the laryngeal view. The necessity of external laryngeal manipulation will be recorded.	when laryngoscope is appropriately placed during intubation, approximately 2 seconds
Secondary	magill forceps	when the nasotracheal tube can not introduced to vocal cord manually, magill forceps can hold the tube to advance the tube through vocal cord. The necessity of magill forceps during intubation will be recorded	when laryngoscope is appropriately placed during intubation, approximately 5 seconds
Secondary	IDS (intubation difficulty scale)	IDS score is the sum of the following seven variables: N1: the number of intubation attempts>1 N2: the number of operators. 1 N3: the number of alternative intubation techniques used N4: glottic exposure (Cormack Lehane grade minus 1) N5: Lifting force required during laryngoscopy (0=normal; 1=increased) N6: necessity for external laryngeal pressure (0=not applied; 1=applied) N7: position of the vocal cords at intubation (0=abduction/ not visualized; 1=adduction)	during intubation, approximately 90 seconds
Secondary	numeric rating scale for intubation	0-10 (0; no difficulty, 10: hardest)	during intubation, approximately 90 seconds
Secondary	grade of bleeding	After confirmation of successful intubation, Yankauer suction was introduced to access the intraoral bleeding during intubation.; Grade is 4 points scale (none/trace/moderate/severe).	10 seconds after completion of intubation