LaminectomyPhase 4NCT01113723

Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device

A Phase 4 study testing Fiberoptic bronchoscope and CMAC in people with Laminectomy, 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Laminectomy
What is being tested?: Fiberoptic bronchoscope and CMAC
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: Dec 2009to Feb 2012
Phase: Phase 4
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with an unstable Cervical-spine as a result of C-spine injury.
Patients scheduled to undergo inpatient surgical procedures under general anesthesia.
Willingness and ability to sign an informed consent document.
18-80 years of age.
ASA Class I - III adults of either sex

Who cannot join

Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation.
Patients with a history of oral-pharyngeal cancer or reconstructive surgery.
Emergency surgeries.
Any other conditions which may interfere with the conduct of the study.

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 Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine

The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.

Conditions: Laminectomy
Being tested: Fiberoptic bronchoscope, CMAC
Keywords: C-MAC, Fiberoptic bronchoscope, Laryngoscopy, Cervical spine injury, Glottic view, Tracheal intubation

What participants receive

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

Fiberoptic bronchoscopeDevice
Fiberoptic bronchoscope device
CMACDevice
CMAC Device

Study groups in NCT01113723
Study group	Role	What they receive
CMAC Device	Other	CMAC Intubating device time to achieve successful tracheal intubation. Receives: Device: CMAC
Fiberoptic bronchoscope	Active comparator	Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation. Receives: Device: Fiberoptic bronchoscope

What is being measured

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

Intubation Time (Seconds)
Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube
Measured: 3 minutes
Time to Confirm the Placement of the Tracheal Tube
It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform
Measured: up tp 3 minutes

Secondary outcomes (1)

Time to Obtain Glottis Visualization (Seconds)
Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine.
Measured: 1 minute

Timeline

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

Dec 2009Feb 2012

First posted30 Apr 2010 (estimated)
Study startDec 2009
Primary completionFeb 2012
Study completionFeb 2012

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 LaminectomyStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe 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 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01113723
Sponsor's protocol ID: Pro00019845
Status last verified: Feb 2016
First submitted: 23 Apr 2010
Last updated: 9 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Enrolling by invitationPhase 4
Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care
Spinal Surgery, Spinal Fusion
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury
Spinal Cord Injury, Acute Spinal Cord Injury (SCI)

All Laminectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Prospective Study to Compare Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine
ClinicalTrials.gov ID: NCT01113723
Acronym / sponsor ID: Pro00019845
Conditions: Laminectomy
Keywords: C-MAC, Fiberoptic bronchoscope, Laryngoscopy, Cervical spine injury, Glottic view, Tracheal intubation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: Dec 2009
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 30 Apr 2010 (estimated)
Results: Posted 9 Mar 2016

Clinical summary

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

Study design

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

Arm	Type	Receives
CMAC Device	Other	Device: CMACCMAC Intubating device time to achieve successful tracheal intubation.
Fiberoptic bronchoscope	Active comparator	Device: Fiberoptic bronchoscopeFiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with an unstable Cervical-spine as a result of C-spine injury.
Patients scheduled to undergo inpatient surgical procedures under general anesthesia.
Willingness and ability to sign an informed consent document.
18-80 years of age.
ASA Class I - III adults of either sex

Key exclusion criteria (4 listed)

Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation.
Patients with a history of oral-pharyngeal cancer or reconstructive surgery.
Emergency surgeries.
Any other conditions which may interfere with the conduct of the study.

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
Fiberoptic bronchoscopeFiberoptic bronchoscope device	Device	Fiberoptic bronchoscope
CMACCMAC Device	Device	CMAC Device

Primary outcome

Intubation Time (Seconds)
Time frame: 3 minutes
Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube
Time to Confirm the Placement of the Tracheal Tube
Time frame: up tp 3 minutes
It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform

1 secondary outcome

Time to Obtain Glottis Visualization (Seconds)
Time frame: 1 minute

Results and safety

Results posted to the registry on 9 Mar 2016, 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 Device	70	70
Fiberoptic Bronchoscope	70	70

Primary outcome: Intubation Time (Seconds)

Time frame: 3 minutes. Mean (Standard Deviation). Unit: Seconds

Measure	CMAC Device n = 70	Fiberoptic Bronchoscope n = 70
Value	35 (22)	59 (36)

Primary outcome: Time to Confirm the Placement of the Tracheal Tube

Time frame: up tp 3 minutes. Mean (Standard Deviation). Unit: Seconds

Measure	CMAC Device n = 70	Fiberoptic Bronchoscope n = 70
Value	62 (31)	99 (38)

1 secondary outcome is 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 Device	0 of 70 (0%)	0 of 70 (0%)	Not reported
Flexible Fiberoptic Scope (FFS)	0 of 70 (0%)	0 of 70 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Laminectomy

Enrolling by invitationPhase 4
Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care
Spinal Surgery, Spinal Fusion
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury
Spinal Cord Injury, Acute Spinal Cord Injury (SCI)

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fiberoptic bronchoscope and CMAC in people with Laminectomy, 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 5 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 9 Mar 2016. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2016). 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 (Seconds) (time frame: 3 minutes). The study lists 2 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 NCT01113723.

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 9 Mar 2016.