Difficult Endotracheal IntubationNCT01215695
Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
A study testing aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) in people with Difficult Endotracheal Intubation, run by University of Louisville at 1 site in United States.
Trial summary
We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Endotracheal Intubation
- What is being tested?
- aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 35
- Thyromental distance < 6 cm
- Sterno-mental distance < 12 cm
- Mallampati grade 3 and 4
- Interincisor distance < 38 mm
- Status of dentition: presence of buckteeth
Show all 10Show fewer
- Neck movement < 35°
- Neck circumference >43 cm at the level of the thyroid cartilage
- Patients with immobilized cervical spine (C-collar in place).
- History of difficult laryngoscopy or intubation
Who cannot join
- Full stomach
- Hiatal hernia
- Severe GERD (Gastroesophageal reflux disease)
- Tumors of the upper airway
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).
- Conditions
- Difficult Endotracheal Intubation
- Being tested
- aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD), Control
- Keywords
- Intubation, Endotracheal, Endotracheal Intubation, adverse events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)Device
Also called video-stylet
The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
ControlDevice
pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) Receives: Device: Control |
| Intervention | Experimental | Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). Receives: Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time
divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
Measured: 120 seconds
Secondary outcomes (4)
The Number of Intubation Attempts
counted as each approach of the ETT to the glottic entrance.
Measured: 30 minutes
Neck Movement
One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.
Measured: 30 minutes
Laryngeal View Grade of 1 or 2
The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).
Measured: 30 minutes
Ease of Intubation
After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.
Measured: 2-4 hours after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2013
- Study completionDec 2013
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 Difficult Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rainer Lenhardt, University of Louisville
- Investigators
- Rainer Lenhardt, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215695
- Sponsor's protocol ID
- UofL IRB #10.0300
- Status last verified
- Aug 2017
- First submitted
- 22 Jul 2010
- Last updated
- 8 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.
PubMed 24842175
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
- ClinicalTrials.gov ID
- NCT01215695
- Acronym / sponsor ID
- UofL IRB #10.0300
- Conditions
- Difficult Endotracheal Intubation
- Keywords
- Intubation, Endotracheal, Endotracheal Intubation, adverse events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 27 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: ControlPatients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) |
| Intervention | Experimental | Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- BMI > 35
- Thyromental distance < 6 cm
- Sterno-mental distance < 12 cm
- Mallampati grade 3 and 4
- Interincisor distance < 38 mm
Key exclusion criteria (4 listed)
- Full stomach
- Hiatal hernia
- Severe GERD (Gastroesophageal reflux disease)
- Tumors of the upper airway
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 |
|---|---|---|
| aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)Also: video-styletThe aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor. | Device | Intervention |
| Controlpre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope | Device | Control |
Primary outcome
Intubation Time
Time frame: 120 seconds
divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
4 secondary outcomes
The Number of Intubation Attempts
Time frame: 30 minutes
Neck Movement
Time frame: 30 minutes
Laryngeal View Grade of 1 or 2
Time frame: 30 minutes
Ease of Intubation
Time frame: 2-4 hours after intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24842175Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.
Related trials for Difficult Endotracheal Intubation
Not yet recruiting
Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation
Airway Management, Endotracheal Intubation
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.
Rainer Lenhardt, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) in people with Difficult Endotracheal Intubation, run by University of Louisville 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 10 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 8 Sep 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 27 Jul 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?
Intubation Time (time frame: 120 seconds). 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 NCT01215695, 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 8 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.