Intubation; DifficultNCT02405390
Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy
A study testing Video Laryngoscopy, Direct Laryngoscopy and Storz C-Mac® laryngoscope in people with Intubation; Difficult and Cervical Spine Injury, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL). Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Intubation; Difficult, Cervical Spine Injury
- What is being tested?
- Video Laryngoscopy, Direct Laryngoscopy and Storz C-Mac® laryngoscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jun 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients being orally intubated in the Operating Room as per standard anesthesia procedures
Who cannot join
- previous history of cervical spine injury or surgery
- craniofacial abnormalities
- airway congenital abnormalities
- airway prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy (Storz C-Mac®) Versus Direct Laryngoscopy
The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL).
The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.
Read the detailed description
Investigator initiated single site prospective and randomized controlled trial.
- Conditions
- Intubation; Difficult, Cervical Spine Injury
- Being tested
- Video Laryngoscopy, Direct Laryngoscopy, Storz C-Mac® laryngoscope
- Keywords
- Storz C-Mac®, Pediatric Airway, Cervical Spine Injury, Trauma Airway Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video LaryngoscopyProcedure or surgery
Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Direct LaryngoscopyProcedure or surgery
Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Storz C-Mac® laryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Video Laryngoscopy | Experimental | Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope' Receives: Procedure: Video Laryngoscopy; Device: Storz C-Mac® laryngoscope |
| Direct Laryngoscopy | Active comparator | Some patients will be intubated with a direct (conventional) laryngoscope Receives: Procedure: Direct Laryngoscopy; Device: Storz C-Mac® laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head Motion - Extension or Flexion
Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.
Measured: During the process of intubation (less than one minute)
Secondary outcomes (1)
Time for Intubation
Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.
Measured: During the process of intubation (less than one minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 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.
- Other trials for Intubation; DifficultStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University
- Responsible party
- Sponsor
- Investigators
- Jose Vargas Loayza, MD, Principal investigator, Miami Children's Hospital Pediatric Emergency Medicine FellowVincenzo Maniaci, MD, Study director, Miami Children's Hospital Pediatric Emergency Medicine Attending
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405390
- Sponsor's protocol ID
- 20141780
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2015
- Last updated
- 12 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy (Storz C-Mac®) Versus Direct Laryngoscopy
- ClinicalTrials.gov ID
- NCT02405390
- Acronym / sponsor ID
- 20141780
- Conditions
- Intubation; Difficult, Cervical Spine Injury
- Keywords
- Storz C-Mac®, Pediatric Airway, Cervical Spine Injury, Trauma Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's HospitalUniversity, hospital or other
- Collaborators
- Florida International University
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Posted 12 Jun 2017
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 evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL).
The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.
Detailed description
Investigator initiated single site prospective and randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Laryngoscopy | Experimental | Procedure: Video Laryngoscopy, Device: Storz C-Mac® laryngoscopeSome patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope' |
| Direct Laryngoscopy | Active comparator | Procedure: Direct Laryngoscopy, Device: Storz C-Mac® laryngoscopeSome patients will be intubated with a direct (conventional) laryngoscope |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients being orally intubated in the Operating Room as per standard anesthesia procedures
Key exclusion criteria (4 listed)
- previous history of cervical spine injury or surgery
- craniofacial abnormalities
- airway congenital abnormalities
- airway prior to surgery
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 |
|---|---|---|
| Video LaryngoscopyHead motion will be measured by using Polhemus Patriot™ electromagnetic tracking system | Procedure or surgery | Video Laryngoscopy |
| Direct LaryngoscopyTime for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords | Procedure or surgery | Direct Laryngoscopy |
| Storz C-Mac® laryngoscope | Device | Direct Laryngoscopy, Video Laryngoscopy |
Primary outcome
Head Motion - Extension or Flexion
Time frame: During the process of intubation (less than one minute)
Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.
1 secondary outcome
Time for Intubation
Time frame: During the process of intubation (less than one minute)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Miami Children's Hospital Research Institute WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jose Vargas Loayza, MD principal investigator
Miami Children's Hospital Pediatric Emergency Medicine Fellow
Vincenzo Maniaci, MD study director
Miami Children's Hospital Pediatric Emergency Medicine Attending
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngoscopy, Direct Laryngoscopy and Storz C-Mac® laryngoscope in people with Intubation; Difficult and Cervical Spine Injury, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital 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 1 inclusion and 4 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 12 Jun 2017. 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 12 Jun 2017). 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?
Head Motion - Extension or Flexion (time frame: During the process of intubation (less than one minute)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2017.