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Comparison of the Videolaryngoscopes With Manual In-line Stabilization

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02647606
Enrollment
120
Registered
2016-01-06
Start date
2016-01-31
Completion date
2017-02-28
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Surgery, Maxillofacial Surgery

Brief 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.

Interventions

PROCEDUREMILS

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

McGrath videolaryngoscope will be used for intubation

Pentax AWS videolaryngoscope will be used for intubation

DEVICEMacintosh laryngoscope

Macintosh laryngoscope will be used for intubation

Sponsors

Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
time for intubationfrom holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds
Cormack Lehane Laryngeal viewwhen laryngoscope is appropriately placed during intubation, approximately 2 seconds
POGP scorewhen laryngoscope is appropriately placed during intubation, approximately 2 secondsPercentage of glottic opening(POGO)

Secondary

MeasureTime frameDescription
numeric rating scale for intubationduring intubation, approximately 90 seconds0-10 (0; no difficulty, 10: hardest)
external laryngeal manipulationwhen laryngoscope is appropriately placed during intubation, approximately 2 secondsWhen 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.
grade of bleeding10 seconds after completion of intubationAfter confirmation of successful intubation, Yankauer suction was introduced to access the intraoral bleeding during intubation. Grade is 4 points scale (none/trace/moderate/severe).
magill forcepswhen laryngoscope is appropriately placed during intubation, approximately 5 secondswhen 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
IDS (intubation difficulty scale)during intubation, approximately 90 secondsIDS 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026