N/A
N=28
Study: Study to Compare Video Miller Device to Direct Laryngoscopy
Surgeries Undergoing General Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT01371032 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Time to Obtain Glottic View — 9.2; 8.4 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VideoMiller (Device); Direct Laryngoscopy (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Obtain Glottic View |
9.2; 8.4 | — |
| PRIMARY Intubation Time |
21; 28 | — |
| PRIMARY Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform |
61; 59 | — |
| SECONDARY Glottis Visualization Using POGO Score |
94; 93.2 | — |
| SECONDARY Glottis Visualization Using Cormack Lehane |
12; 12; 2; 2 | — |
| SECONDARY Number of Participants Intubated With 1 and > 1 Intubation Attempts |
11; 12; 3; 2 | — |
Summary
The purpose of this study is to compare:
the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure.
The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.
Eligibility Criteria
Inclusion Criteria
- Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.
- Obtaining signed the informed consent by their parents or legal guardian.
- American Society of Anaesthesiologists (ASA) physical status classification I - II or III
Exclusion Criteria
- Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation
- Patients with facial abnormalities, and/or oral-pharyngeal malformation.
- Emergency operation
Data sourced from ClinicalTrials.gov (NCT01371032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.