IntubationNCT00956592

Clinical Evaluation of the Storz CMAC Laryngoscope

A study testing CMAC video laryngoscope and Macintosh laryngoscope in people with Intubation and Airway Management, run by Oregon Health and Science University 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

This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Intubation, Airway Management
What is being tested?: CMAC video laryngoscope and Macintosh laryngoscope
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Dec 2010
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:
mallampati classification 3
mallampati classification 4
Reduced mouth opening (<3cm)
reduced cervical motion
history of previous difficult intubation or multiple laryngoscopy attempts

Who cannot join

Patients less than 18 years old, patients who are not fasted (>6 hrs. NPO)
Patients who have contraindications to the administration of neuromuscular blocking drugs
Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view
Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult

Read the detailed description

Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.

Conditions: Intubation, Airway Management
Being tested: CMAC video laryngoscope, Macintosh laryngoscope
Keywords: Video laryngoscopy, Intubation success, Difficult airway, CMAC laryngoscope

What participants receive

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

CMAC video laryngoscopeDevice
Also called CMAC, Storz laryngoscope
Intubation utilizing the assistance of video enhancement
Macintosh laryngoscopeDevice
Also called Mac blade
Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade

Study groups in NCT00956592
Study group	Role	What they receive
CMAC Video laryngoscope	Active comparator	Subjects will have their intubation attempted first with the CMAC video laryngoscope Receives: Device: CMAC video laryngoscope
Macintosh blade	Active comparator	Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade Receives: Device: Macintosh laryngoscope

What is being measured

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

Measure of Intubation Success
Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure
Measured: During each intubation in a 14 month period

Secondary outcomes (5)

Intubation Time
Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation
Measured: During laryngoscopy procedure
Number of Participants Intubated With a Rescue Device
Measured: 1 year
Number of Participants With Complications
Measured: 1 year
Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.
Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved
Measured: 1 year
Number of Particpants Requiring Adjuncts to Assist Intubation
Measured: 1 year

Timeline

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

Oct 2009Dec 2010

First posted11 Aug 2009 (estimated)
Study startOct 2009
Primary completionDec 2010
Study completionDec 2010

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 IntubationStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00956592
Sponsor's protocol ID: IRB00003272
Status last verified: Apr 2018
First submitted: 10 Aug 2009
Last updated: 5 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jungbauer A, Schumann M, Brunkhorst V, Borgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth. 2009 Apr;102(4):546-50. doi: 10.1093/bja/aep013. Epub 2009 Feb 20.
PubMed 19233881

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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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult
ClinicalTrials.gov ID: NCT00956592
Acronym / sponsor ID: IRB00003272
Conditions: Intubation, Airway Management
Keywords: Video laryngoscopy, Intubation success, Difficult airway, CMAC laryngoscope
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Study start: Oct 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 11 Aug 2009 (estimated)
Results: Posted 9 Mar 2011

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CMAC Video laryngoscope	Active comparator	Device: CMAC video laryngoscopeSubjects will have their intubation attempted first with the CMAC video laryngoscope
Macintosh blade	Active comparator	Device: Macintosh laryngoscopePatients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:

Key exclusion criteria (4 listed)

Patients less than 18 years old, patients who are not fasted (>6 hrs. NPO)
Patients who have contraindications to the administration of neuromuscular blocking drugs
Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view
Patients who are deemed to difficult and dangerous to anesthetize without first securing an 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
CMAC video laryngoscopeAlso: CMAC, Storz laryngoscopeIntubation utilizing the assistance of video enhancement	Device	CMAC Video laryngoscope
Macintosh laryngoscopeAlso: Mac bladePatients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade	Device	Macintosh blade

Primary outcome

Measure of Intubation Success
Time frame: During each intubation in a 14 month period
Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure

5 secondary outcomes

Intubation Time
Time frame: During laryngoscopy procedure
Number of Participants Intubated With a Rescue Device
Time frame: 1 year
Number of Participants With Complications
Time frame: 1 year
Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.
Time frame: 1 year
Number of Particpants Requiring Adjuncts to Assist Intubation
Time frame: 1 year

Results and safety

Results posted to the registry on 9 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CMAC Video Laryngoscope	150	149
Macintosh Blade	150	147

Primary outcome: Measure of Intubation Success

Time frame: During each intubation in a 14 month period. Number (95% Confidence Interval). Unit: Participants

Measure	CMAC Video Laryngoscope n = 149	Macintosh Blade n = 147
Value	138 (132 to 144)	124 (117 to 131)

Population analysed: 4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CMAC Video Laryngoscope	0 of 150 (0%)	0 of 150 (0%)	Not reported
Macintosh Blade	0 of 150 (0%)	0 of 150 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19233881Jungbauer A, Schumann M, Brunkhorst V, Borgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth. 2009 Apr;102(4):546-50. doi: 10.1093/bja/aep013. Epub 2009 Feb 20.

Related trials for Intubation

Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway 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.

Michael Aziz, MD principal investigator

Oregon Health and Science University

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

Questions about this trial

What is this clinical trial studying?

A study testing CMAC video laryngoscope and Macintosh laryngoscope in people with Intubation and Airway Management, run by Oregon Health and Science University 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 6 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 5 Apr 2018. 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 9 Mar 2011). 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?

Measure of Intubation Success (time frame: During each intubation in a 14 month period). 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 NCT00956592, 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 5 Apr 2018.