Cervical Spine Biomechanics During Endotracheal Intubation
Primary Purpose
Spinal Diseases, Other Biomechanical Lesions of Cervical Region, Tracheal Intubation Morbidity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endotracheal intubation
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Diseases focused on measuring Cervical spine, Endotracheal intubation, Laryngoscope, Biomechanics
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Airtraq laryngoscope
Macintosh laryngoscope
Arm Description
The Airtraq is an alternative indirect laryngoscope that appears to cause less cervical spine motion during intubation that conventional direct laryngoscopy (Macintosh blade)
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.
Outcomes
Primary Outcome Measures
Cervical spine segmental intervertebral motion
Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation.
Secondary Outcome Measures
Laryngoscope blade force distribution
"Pressure-mat" technology is used to measure spacially distributed forces applied by the laryngoscope blade during endotracheal intubation.
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.
Full Information
NCT ID
NCT01369381
First Posted
May 31, 2011
Last Updated
August 3, 2012
Sponsor
University of Iowa
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT01369381
Brief Title
Cervical Spine Biomechanics During Endotracheal Intubation
Official Title
Intubation Mechanics of the Stable and Unstable Cervical Spine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), Colorado State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Diseases, Other Biomechanical Lesions of Cervical Region, Tracheal Intubation Morbidity
Keywords
Cervical spine, Endotracheal intubation, Laryngoscope, Biomechanics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Airtraq laryngoscope
Arm Type
Experimental
Arm Description
The Airtraq is an alternative indirect laryngoscope that appears to cause less cervical spine motion during intubation that conventional direct laryngoscopy (Macintosh blade)
Arm Title
Macintosh laryngoscope
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endotracheal intubation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cervical spine segmental intervertebral motion
Description
Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation.
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.
Secondary Outcome Measure Information:
Title
Laryngoscope blade force distribution
Description
"Pressure-mat" technology is used to measure spacially distributed forces applied by the laryngoscope blade during endotracheal intubation.
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.
Title
Glottic visualization
Description
An image of the glottis during intubation is obtained for off-line measurement of the percentage of glottic opening as seen by the laryngoscopist.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley J Hindman, M.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18043056
Citation
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.
Results Reference
background
PubMed Identifier
19104166
Citation
Santoni 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.
Results Reference
background
PubMed Identifier
21326090
Citation
Hindman 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.
Results Reference
background
PubMed Identifier
18477276
Citation
Hirabayashi 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.
Results Reference
background
PubMed Identifier
19512871
Citation
Turkstra 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.
Results Reference
background
PubMed Identifier
35551148
Citation
Hindman 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.
Results Reference
derived
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Cervical Spine Biomechanics During Endotracheal Intubation
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