Surgeries Undergoing General AnesthesiaNCT01371032

Study: Study to Compare Video Miller Device to Direct Laryngoscopy

A study testing VideoMiller and Direct Laryngoscopy in people with Surgeries Undergoing General Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages Up to 3 years
Conditions the study is for: Surgeries Undergoing General Anesthesia
What is being tested?: VideoMiller and Direct Laryngoscopy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars Sinai Medical center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: A Randomized, Prospective Study to Compare the Video Miller Device to Direct Laryngoscopy Using a Standard Pediatric Miller Blade for Tracheal Intubation of Children < 3 Years of Age Undergoing General Anesthesia

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.

Conditions: Surgeries Undergoing General Anesthesia
Being tested: VideoMiller, Direct Laryngoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VideoMillerDevice
Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
Direct LaryngoscopyDevice
Video-Miller laryngoscope, without screen (Direct laryngoscopy group)

Study groups in NCT01371032
Study group	Role	What they receive
Video-Miller laryngoscope	Active comparator	using the screen (Video laryngoscopy group) Receives: Device: VideoMiller
Direct laryngoscopy	Active comparator	without use the screen (Direct laryngoscopy group) Receives: Device: Direct Laryngoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Obtain Glottic View
Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)
Measured: Times following initial insertion of laryngoscope blade to obtain glottic view
Intubation Time
Times following initial insertion of laryngoscope blade to placement of tracheal tube
Measured: Times from insertion of laryngoscope blade to placement of tracheal tube
Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform
Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform
Measured: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform

Secondary outcomes (3)

Glottis Visualization Using POGO Score
POGO score represents the percentage of glottic opening seen (from 0-100%)
Measured: During intubation procedure, up to 3 minutes
Glottis Visualization Using Cormack Lehane
Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation
1. Full view of glottis 68-74% <1%
2. a Partial view of glottis 21-24% 4.3-13.4%
2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare
Measured: During intubation procedure, up to 3 minutes
Number of Participants Intubated With 1 and > 1 Intubation Attempts
Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after > 1 intubation attempts
Measured: During intubation procedure, up to 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Dec 2015

First posted10 Jun 2011 (estimated)
Study startJun 2011
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Surgeries Undergoing General AnesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01371032
Sponsor's protocol ID: Pro00024542
Status last verified: Aug 2021
First submitted: 9 Jun 2011
Last updated: 21 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.
PubMed 37171122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."
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Impact of Intraoperative Oxygenation Practices on Patient Outcomes
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Evaluation of Anterior Neck Ultrasound in Predicting Difficult Airway in Obese Patients
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All Surgeries Undergoing General Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Prospective Study to Compare the Video Miller Device to Direct Laryngoscopy Using a Standard Pediatric Miller Blade for Tracheal Intubation of Children < 3 Years of Age Undergoing General Anesthesia
ClinicalTrials.gov ID: NCT01371032
Acronym / sponsor ID: Pro00024542
Conditions: Surgeries Undergoing General Anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: Jun 2011
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 10 Jun 2011 (estimated)
Results: Posted 21 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare:

The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Video-Miller laryngoscope	Active comparator	Device: VideoMillerusing the screen (Video laryngoscopy group)
Direct laryngoscopy	Active comparator	Device: Direct Laryngoscopywithout use the screen (Direct laryngoscopy group)

Who may qualify

Ages: Up to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VideoMillerVideo-Miller laryngoscope, using the screen (Video laryngoscopy group)	Device	Video-Miller laryngoscope
Direct LaryngoscopyVideo-Miller laryngoscope, without screen (Direct laryngoscopy group)	Device	Direct laryngoscopy

Primary outcome

Time to Obtain Glottic View
Time frame: Times following initial insertion of laryngoscope blade to obtain glottic view
Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)
Intubation Time
Time frame: Times from insertion of laryngoscope blade to placement of tracheal tube
Times following initial insertion of laryngoscope blade to placement of tracheal tube
Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform
Time frame: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform
Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform

3 secondary outcomes

Glottis Visualization Using POGO Score
Time frame: During intubation procedure, up to 3 minutes
Glottis Visualization Using Cormack Lehane
Time frame: During intubation procedure, up to 3 minutes
Number of Participants Intubated With 1 and > 1 Intubation Attempts
Time frame: During intubation procedure, up to 3 minutes

Results and safety

Results posted to the registry on 21 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Video-Miller Laryngoscope	14	14
Direct Laryngoscopy	14	14

Primary outcome: Time to Obtain Glottic View

Time frame: Times following initial insertion of laryngoscope blade to obtain glottic view. Mean (Standard Deviation). Unit: seconds

Measure	Video-Miller Laryngoscope n = 14	Direct Laryngoscopy n = 14
Value	9.2 (5)	8.4 (6.4)

Primary outcome: Intubation Time

Time frame: Times from insertion of laryngoscope blade to placement of tracheal tube. Mean (Standard Deviation). Unit: Seconds

Measure	Video-Miller Laryngoscope n = 14	Direct Laryngoscopy n = 14
Value	21 (11)	28 (20)

Primary outcome: Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform

Time frame: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform. Mean (Standard Deviation). Unit: seconds

Measure	Video-Miller Laryngoscope n = 14	Direct Laryngoscopy n = 14
Value	61 (37)	59 (30)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: One day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Video-Miller Laryngoscope	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Direct Laryngoscopy	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37171122Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.

Related trials for Surgeries Undergoing General Anesthesia

Not yet recruiting
Pre-induction Norepinephrine in Septic Patients Undergoing Surgery
Sepsis, Hypotension
RecruitingPhase 3
Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation and Bolus Maintenance in Adults
Neuromuscular Blockade
Active, not recruitingObservational study
"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."
Postoperative Cognitive Deficit (POCD)
Recruiting
Impact of Intraoperative Oxygenation Practices on Patient Outcomes
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Not yet recruitingObservational study
Evaluation of Anterior Neck Ultrasound in Predicting Difficult Airway in Obese Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roya Yumul, MD,PhD principal investigator

Cedars-Sinai Medical Center

Ronald H Wender, MD study chair

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VideoMiller and Direct Laryngoscopy in people with Surgeries Undergoing General Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Obtain Glottic View (time frame: Times following initial insertion of laryngoscope blade to obtain glottic view). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01371032, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.