Spinal DiseasesNCT01369381
Cervical Spine Biomechanics During Endotracheal Intubation
A study testing Endotracheal intubation in people with Spinal Diseases and Other Biomechanical Lesions of Cervical Region, run by University of Iowa at 1 site in United States.
Trial summary
Current methods for endotracheal intubation in the presence of cervical spine (c-spine) instability are not evidence-based. This is so because the relationships between the forces applied during intubation (by the laryngoscope) and the resulting c-spine movement have not yet been quantitatively characterized. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Diseases, Other Biomechanical Lesions of Cervical Region, Tracheal Intubation Morbidity
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient Height: 5-feet, 0-inches to 6-feet, 0-inches
- Patient body mass index: less than 30 kg/m2
- Planned surgery requires use of C-arm fluoroscopy
- Planned surgery to take place at University of Iowa and requires general anesthesia and orotracheal intubation
Who cannot join
- The patient is a prisoner
- The patient is pregnant
- The patient is not competent to personally give consent
- Neurological signs and symptoms indicating cervical spinal cord myelopathy
- Cervical spine images demonstrating anatomic instability, traumatic injury, significant cervical stenosis, and/or spinal immobility
- Condition associated with cervical spine anatomic abnormalities such as Rheumatoid arthritis, Down Syndrome, Ankylosing spondylitis, Osteogenesis imperfecta
Show all 22Show fewer
- Prior cervical spine surgery of any type
- History of difficult endotracheal intubation
- Currently symptomatic gastroesophageal reflux disease
- Currently symptomatic asthma or other reactive airway disease
- Any history of coronary artery disease
- Any history of cerebral aneurysm(s)
- History of vocal cord and/or glottic disease or dysfunction
- Contraindication to receiving 100% oxygen
- Systolic blood pressure greater than 180 mmHg
- Diastolic blood pressure greater than 100 mmHg
- American Society of Anesthesiologists Physical Status class of 4, 5, or 6
- Known allergy or other adverse response to study drugs: midazolam, lidocaine, fentanyl, propofol [eggs, soy beans], rocuronium, or sevoflurane.
- Mallampati oropharyngeal class of III or IV
- Thyromental distance less than 6.0 cm
- Sternomental distance less than 12.5 cm
- Maxillary incisors loss or in poor condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Intubation Mechanics of the Stable and Unstable Cervical Spine
Current methods for endotracheal intubation in the presence of cervical spine (c-spine) instability are not evidence-based. This is so because the relationships between the forces applied during intubation (by the laryngoscope) and the resulting c-spine movement have not yet been quantitatively characterized. As a result, with the current level of knowledge, it is not known, and it is not possible to predict, which types of c-spine instability have the greatest risk of cervical spinal cord injury with intubation. This shortcoming makes it impossible to know which intubation devices and techniques are likely to be safest in the presence of c-spine instability.
To address this critical lack of knowledge, the overarching purpose of the proposed research is to: 1) quantitatively relate c-spine movement that results from the forces applied to the peri-airway tissues during intubation (force-motion relationships), and 2) use these data to develop a mathematical model of the c-spine that will predict which types of c-spine instability result in the greatest amount of abnormal c-spine motion and associated spinal cord compression during intubation.
This clinical study will utilize laryngoscope blades that are instrumented with a high resolution pressure mapping system to make high-resolution measurements of the forces and pressures of intubation while making simultaneous measurements of c-spine motion. In this study, study subjects will be intubated using both a conventional (Macintosh) laryngoscope and an alternative (Airtraq) laryngoscope. By using two different laryngoscopes, we, the investigators, will introduce forces of differing magnitudes and distributions to peri-airway tissues. The Airtraq does not require a direct line of sight to visualize the vocal cords, and among the various new alternative laryngoscopes it is the only one that has been shown to result in 30-50% less cervical motion than a conventional (Macintosh) laryngoscope. Accordingly, we hypothesize 1) 30-50% less force will be applied with the Airtraq laryngoscope than with the conventional (Macintosh) laryngoscope and 2) 30-50% less c-spine motion will occur with the Airtraq. By studying (intubating) each subject twice, any differences in the c-spine force-motion relationships between devices will be due to the devices themselves. By studying each subject twice, we can account for (and eliminate) differences among study subjects in c-spine biomechanical properties.
- Conditions
- Spinal Diseases, Other Biomechanical Lesions of Cervical Region, Tracheal Intubation Morbidity
- Being tested
- Endotracheal intubation
- Keywords
- Cervical spine, Endotracheal intubation, Laryngoscope, Biomechanics
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationProcedure or surgery
Study patients undergo endotracheal intubation using both a conventional direct laryngoscope (Macintosh) and an alternative indirect laryngoscope (Airtraq). The order of intubation (Macintosh then Airtraq--or--Airtraq then Macintosh) is randomized.
| Study group | Role | What they receive |
|---|---|---|
| Airtraq laryngoscope | Experimental | The Airtraq is an alternative indirect laryngoscope that appears to cause less cervical spine motion during intubation that conventional direct laryngoscopy (Macintosh blade) Receives: Procedure: Endotracheal intubation |
| Macintosh laryngoscope | Active comparator | This arm constitutes intubation with a conventional direct laryngoscopy with a Macintosh blade which has been shown to result in cervical spine extension, particularly in the upper cervical segments. Receives: Procedure: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical spine segmental intervertebral motion
Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation.
Measured: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Secondary outcomes (2)
Laryngoscope blade force distribution
"Pressure-mat" technology is used to measure spacially distributed forces applied by the laryngoscope blade during endotracheal intubation.
Measured: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Glottic visualization
An image of the glottis during intubation is obtained for off-line measurement of the percentage of glottic opening as seen by the laryngoscopist.
Measured: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal DiseasesStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Colorado State University
- Responsible party
- Principal investigator, Bradley J. Hindman, University of Iowa
- Investigators
- Bradley J Hindman, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369381
- Sponsor's protocol ID
- 201102721
- Other IDs
- R01EB012048
- Status last verified
- Aug 2012
- First submitted
- 31 May 2011
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
LeGrand SA, Hindman BJ, Dexter F, Weeks JB, Todd MM. Craniocervical motion during direct laryngoscopy and orotracheal intubation with the Macintosh and Miller blades: an in vivo cinefluoroscopic study. Anesthesiology. 2007 Dec;107(6):884-91. doi: 10.1097/01.anes.0000291461.62404.46.
PubMed 18043056Santoni BG, Hindman BJ, Puttlitz CM, Weeks JB, Johnson N, Maktabi MA, Todd MM. Manual in-line stabilization increases pressures applied by the laryngoscope blade during direct laryngoscopy and orotracheal intubation. Anesthesiology. 2009 Jan;110(1):24-31. doi: 10.1097/ALN.0b013e318190b556.
PubMed 19104166Hindman BJ, Palecek JP, Posner KL, Traynelis VC, Lee LA, Sawin PD, Tredway TL, Todd MM, Domino KB. Cervical spinal cord, root, and bony spine injuries: a closed claims analysis. Anesthesiology. 2011 Apr;114(4):782-95. doi: 10.1097/ALN.0b013e3182104859.
PubMed 21326090Hirabayashi Y, Fujita A, Seo N, Sugimoto H. A comparison of cervical spine movement during laryngoscopy using the Airtraq or Macintosh laryngoscopes. Anaesthesia. 2008 Jun;63(6):635-40. doi: 10.1111/j.1365-2044.2008.05480.x.
PubMed 18477276Turkstra TP, Pelz DM, Jones PM. Cervical spine motion: a fluoroscopic comparison of the AirTraq Laryngoscope versus the Macintosh laryngoscope. Anesthesiology. 2009 Jul;111(1):97-101. doi: 10.1097/ALN.0b013e3181a8649f.
PubMed 19512871Hindman BJ, Dexter F, Gadomski BC, Puttlitz CM. Relationship Between Glottic View and Intubation Force During Macintosh and Airtraq Laryngoscopy and Intubation. Anesth Analg. 2022 Oct 1;135(4):815-819. doi: 10.1213/ANE.0000000000006082. Epub 2022 May 13.
PubMed 35551148
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation Mechanics of the Stable and Unstable Cervical Spine
- ClinicalTrials.gov ID
- NCT01369381
- Acronym / sponsor ID
- 201102721
- Conditions
- Spinal Diseases, Other Biomechanical Lesions of Cervical Region, Tracheal Intubation Morbidity
- Keywords
- Cervical spine, Endotracheal intubation, Laryngoscope, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Colorado State University
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current methods for endotracheal intubation in the presence of cervical spine (c-spine) instability are not evidence-based. This is so because the relationships between the forces applied during intubation (by the laryngoscope) and the resulting c-spine movement have not yet been quantitatively characterized. As a result, with the current level of knowledge, it is not known, and it is not possible to predict, which types of c-spine instability have the greatest risk of cervical spinal cord injury with intubation. This shortcoming makes it impossible to know which intubation devices and techniques are likely to be safest in the presence of c-spine instability.
To address this critical lack of knowledge, the overarching purpose of the proposed research is to: 1) quantitatively relate c-spine movement that results from the forces applied to the peri-airway tissues during intubation (force-motion relationships), and 2) use these data to develop a mathematical model of the c-spine that will predict which types of c-spine instability result in the greatest amount of abnormal c-spine motion and associated spinal cord compression during intubation.
This clinical study will utilize laryngoscope blades that are instrumented with a high resolution pressure mapping system to make high-resolution measurements of the forces and pressures of intubation while making simultaneous measurements of c-spine motion. In this study, study subjects will be intubated using both a conventional (Macintosh) laryngoscope and an alternative (Airtraq) laryngoscope. By using two different laryngoscopes, we, the investigators, will introduce forces of differing magnitudes and distributions to peri-airway tissues. The Airtraq does not require a direct line of sight to visualize the vocal cords, and among the various new alternative laryngoscopes it is the only one that has been shown to result in 30-50% less cervical motion than a conventional (Macintosh) laryngoscope. Accordingly, we hypothesize 1) 30-50% less force will be applied with the Airtraq laryngoscope than with the conventional (Macintosh) laryngoscope and 2) 30-50% less c-spine motion will occur with the Airtraq. By studying (intubating) each subject twice, any differences in the c-spine force-motion relationships between devices will be due to the devices themselves. By studying each subject twice, we can account for (and eliminate) differences among study subjects in c-spine biomechanical properties.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airtraq laryngoscope | Experimental | Procedure: Endotracheal intubationThe Airtraq is an alternative indirect laryngoscope that appears to cause less cervical spine motion during intubation that conventional direct laryngoscopy (Macintosh blade) |
| Macintosh laryngoscope | Active comparator | Procedure: Endotracheal intubationThis arm constitutes intubation with a conventional direct laryngoscopy with a Macintosh blade which has been shown to result in cervical spine extension, particularly in the upper cervical segments. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient Height: 5-feet, 0-inches to 6-feet, 0-inches
- Patient body mass index: less than 30 kg/m2
- Planned surgery requires use of C-arm fluoroscopy
- Planned surgery to take place at University of Iowa and requires general anesthesia and orotracheal intubation
Key exclusion criteria (22 listed)
- The patient is a prisoner
- The patient is pregnant
- The patient is not competent to personally give consent
- Neurological signs and symptoms indicating cervical spinal cord myelopathy
- Cervical spine images demonstrating anatomic instability, traumatic injury, significant cervical stenosis, and/or spinal immobility
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 |
|---|---|---|
| Endotracheal intubationStudy patients undergo endotracheal intubation using both a conventional direct laryngoscope (Macintosh) and an alternative indirect laryngoscope (Airtraq). The order of intubation (Macintosh then Airtraq--or--Airtraq then Macintosh) is randomized. | Procedure or surgery | Airtraq laryngoscope, Macintosh laryngoscope |
Primary outcome
Cervical spine segmental intervertebral motion
Time frame: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation.
2 secondary outcomes
Laryngoscope blade force distribution
Time frame: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Glottic visualization
Time frame: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Background: PubMed 18043056LeGrand SA, Hindman BJ, Dexter F, Weeks JB, Todd MM. Craniocervical motion during direct laryngoscopy and orotracheal intubation with the Macintosh and Miller blades: an in vivo cinefluoroscopic study. Anesthesiology. 2007 Dec;107(6):884-91. doi: 10.1097/01.anes.0000291461.62404.46.
- Background: PubMed 19104166Santoni BG, Hindman BJ, Puttlitz CM, Weeks JB, Johnson N, Maktabi MA, Todd MM. Manual in-line stabilization increases pressures applied by the laryngoscope blade during direct laryngoscopy and orotracheal intubation. Anesthesiology. 2009 Jan;110(1):24-31. doi: 10.1097/ALN.0b013e318190b556.
- Background: PubMed 21326090Hindman BJ, Palecek JP, Posner KL, Traynelis VC, Lee LA, Sawin PD, Tredway TL, Todd MM, Domino KB. Cervical spinal cord, root, and bony spine injuries: a closed claims analysis. Anesthesiology. 2011 Apr;114(4):782-95. doi: 10.1097/ALN.0b013e3182104859.
- Background: PubMed 18477276Hirabayashi Y, Fujita A, Seo N, Sugimoto H. A comparison of cervical spine movement during laryngoscopy using the Airtraq or Macintosh laryngoscopes. Anaesthesia. 2008 Jun;63(6):635-40. doi: 10.1111/j.1365-2044.2008.05480.x.
- Background: PubMed 19512871Turkstra TP, Pelz DM, Jones PM. Cervical spine motion: a fluoroscopic comparison of the AirTraq Laryngoscope versus the Macintosh laryngoscope. Anesthesiology. 2009 Jul;111(1):97-101. doi: 10.1097/ALN.0b013e3181a8649f.
- Derived from this study: PubMed 35551148Hindman BJ, Dexter F, Gadomski BC, Puttlitz CM. Relationship Between Glottic View and Intubation Force During Macintosh and Airtraq Laryngoscopy and Intubation. Anesth Analg. 2022 Oct 1;135(4):815-819. doi: 10.1213/ANE.0000000000006082. Epub 2022 May 13.
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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.
Bradley J Hindman, M.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation in people with Spinal Diseases and Other Biomechanical Lesions of Cervical Region, run by University of Iowa 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 4 inclusion and 22 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 7 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cervical spine segmental intervertebral motion (time frame: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.). 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 NCT01369381, which also lists 6 linked publications.
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 7 Aug 2012.