Intubation, IntratrachealNCT05002790
An MRI Study of the Sniffing, Neutral and Extended Head and Neck Positions
A study testing Data collection group in people with Intubation, Intratracheal, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
The traditional method of tracheal intubation requires the insertion of a laryngoscope into the oral cavity and directly visualisation of the glottis. The traditional head position called the sniffing the morning air position; consisting of lower cervical flexion and extension of the atlanto-occipital joint is… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Data collection group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2021to 21 Oct 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide consent
- Volunteers, UHCW staff, aged > 18 years
- Medically able and willing undertake MRI scanning.
- Should pass the MRI safety check list to enter the MRI suite. All participants will complete an MR safety questionnaire immediately prior to their MR scan
Who cannot join
- Unable to provide consent
- Not willing to have MRI scan or unable to undergo MRI scanning
- Known difficult intubation, Restricted or neck extension not possible or presence of arthritis of cervical spine.
- For MRI safety reasons all participants with a cardiac pacemaker or other electronic implants will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
About this study
Official title: A Magnetic Resonance Imaging Study of Changes in the Angle Between the Tracheal and Laryngeal Axes in the Sniffing, Neutral and Extended Head and Neck Positions for Videolaryngoscopy
The traditional method of tracheal intubation requires the insertion of a laryngoscope into the oral cavity and directly visualisation of the glottis. The traditional head position called the sniffing the morning air position; consisting of lower cervical flexion and extension of the atlanto-occipital joint is commonly used to facilitate tracheal intubation in this manner by aligning the oral axes and providing the operator a view of the glottis.
With the advancement of technology, has seen videolaryngoscopes (VL) developed to ease tracheal intubation. With VL, the glottis is seen through a camera connected to a viewing screen either attached to the top of the laryngoscope or connected to a camera screen by cable. One of the main drawbacks with VL is that a good view of the glottis is seen on the screen, but it can be difficult to pass the tracheal tube through the glottis in comparison to the traditional intubation technique described above. One of the main factors the authors suggest is that VL-assisted intubation requires a head and neck position that is different to the sniffing the morning air position.
This study aims to assess the oral axes in three different head and neck positions under MRI to assess which positions improve axial alignment the most.
Read the detailed description
The traditional method of tracheal intubation requires the insertion of a laryngoscope with the left hand into the oral cavity to displace the tongue and directly visualise the glottis.
The sniffing the morning air (or sniffing) position has been traditionally used for tracheal intubation using direct laryngoscopy. This comprises of flexion of the lower cervical spine, extension at the atlanto-occiptal joint and a horizontal level between the tragus of the ear and sternum. The theoretical purpose of this position is to improve the glottic visualisation by aligning the oral, pharyngeal and tracheal axes.
In recent years with the advancement of technology, videolaryngoscopy has become popular and many centres are now using only videolaryngoscopes for tracheal intubation. Visualisation occurs indirectly through fibreoptic or digital channels. Most videolaryngoscopes use two types of blades. The Macintosh type for normal airway and hyper-angulated blade for difficult airway.
Hyperangulated blades such as the Glidescope LoPro (Verathon Inc, Bothwell, WA, USA), McGrath Series 5 X blade (Medtronic, Minneapolis, MN, USA) and Storz C-Mac D-blade (Karl Storz Endoscoke, Tuttlingen, Germany) are more curved than the traditional standard geometry used with direct laryngoscopy and are thought to improve glottis visualisation without significant change in head position. However, visualisation of glottis is one of the three steps involved in videolaryngoscopy assisted tracheal intubation. The other two steps include aligning the tube with the glottic inlet and advancing the tube through the glottis into the trachea.
One of the main drawbacks in videolaryngoscopy is that despite good view of glottis on the screen, it can be difficult to successfully advance the tracheal tube into the trachea. Anterior impingement of the tracheal tube at the sub-glottic region is a recognised problem with hyperangulated and channelled videolaryngoscopes. VL directs the pre-formed tracheal tube anteriorly but the trachea descends posteriorly into the thorax creating an acute angle impeding passage of the tube. This can result in difficult intubation or a failed intubation. Manoeuvres such as tube rotation and rotation of bougie can rectify this problem to some extent.
A previous study found that laryngoscopy was more difficult with hyper-angulated blades in the sniffing position as compared to neutral position, contradictory to traditional laryngoscopy teaching. Intermediary positions between sniffing and supine should be studied as these may balance the needs of maintaining sufficient mouth opening and not hindering angles affecting the axial alignment. Both studies recommend the benefits of a ramped position as it does reduce the time to desaturation and reduces aspiration risk compared to supine neutral positions and should be considered when using hyperangulated blades. .
Using magnetic resonance imaging in awake and healthy patients, Adnet, et al. measured the oral, pharyngeal and tracheal axes using the neutral position, sniffing position and simple head extension and found neither position resulted in perfect alignment of the 3 axes. However, they did not study the effect of position on angle between tracheal and laryngeal axes. The search for further evidence is necessary for VL as there is a paucity of research in with regard to best head and neck position for videolaryngoscopy.
- Conditions
- Intubation, Intratracheal
- Being tested
- Data collection group
- Keywords
- Airway management, Videolaryngoscopy, Hyperangulated blades
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection groupDiagnostic test
Magnetic resonance imaging (MRI) allows measurement of the axes described to suggest which head and neck position would provide best anatomical alignment to reduce anterior impingement.
All the MRI scans will be conducted using 3.0 Tesla (Optima 750w, GE Medical, Milwaukee, WI, USA) using the cervical spine section of the coil. T2-weighted images in the sagittal plane will be acquired using a fast recovery fast spin echo (FRFSE) technique. The scans will take around two and half minutes and a member of the anaesthetic investigator team will be present to facilitate positional changes and maintain consistency. MRI scanning will be performed in following 3 head and neck positions:
Neutral position, Sniffing position and the Extension position.
| Study group | Role | What they receive |
|---|---|---|
| Data collection | Experimental | All 20 anticipated subjects to be scanned under MRI, with data collected and analysed together Receives: Diagnostic Test: Data collection group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle A Measured on MRI
To determine which patient head and neck positioning significantly improves the angle A. It is defined as the angle between the tracheal axis (TA) and laryngeal axis (LA)
Measured: Each subject will undergo 3 MRI scans. Angle A will be measured on each scan at the end of all the scans performed that day. The angles will be measured by 2 investigators.
Secondary outcomes (1)
Angle B, C, D and E Measured Using MRI
The tracheal axis (TA) is defined as a line passing through the centre of intrathoracic part of trachea to the centre of cricoid cartilage. The laryngeal axes (LA) is defined as a line passing through the centre of cricoid cartilage to the base of the epiglottis. The pharyngeal axis (PA) is defined as a line passing through the anterior portion of the atlas and vertebrae C2. The oral axis (OA) is defined as straight line drawn parallel to the hard palate. The line of vision (LV) is defined as the straight line passing through the inferior extremity of the superior incisors and posterior extremity of the superior portion of the cricoid.
Angle B is angle between the laryngeal axes (LA) and pharyngeal axes (LA) Angle C is angle between pharyngeal axes (PA) and oral axes (OA) Angle D angle between laryngeal axes (LA) and line of vision (LV) Angle E angle between line of vision (LV) and pharyngeal axes (PA)
Measured: Each subject will undergo 3 MRI scans. The angles will be measured on each scan at the end of the scanning performed that day. The angles will be measured by 2 investigators.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start5 Aug 2021
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
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 (14)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment Controlled trial without randomisation
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002790
- Sponsor's protocol ID
- 282078
- Status last verified
- Jun 2024
- First submitted
- 4 Aug 2021
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abramson ZR, Susarla S, Tagoni JR, Kaban L. Three-dimensional computed tomographic analysis of airway anatomy. J Oral Maxillofac Surg. 2010 Feb;68(2):363-71. doi: 10.1016/j.joms.2009.09.086. Epub 2010 Jan 15.
PubMed 20116709Adnet F, Borron SW, Dumas JL, Lapostolle F, Cupa M, Lapandry C. Study of the "sniffing position" by magnetic resonance imaging. Anesthesiology. 2001 Jan;94(1):83-6. doi: 10.1097/00000542-200101000-00017.
PubMed 11135726Adnet F, Baillard C, Borron SW, Denantes C, Lefebvre L, Galinski M, Martinez C, Cupa M, Lapostolle F. Randomized study comparing the "sniffing position" with simple head extension for laryngoscopic view in elective surgery patients. Anesthesiology. 2001 Oct;95(4):836-41. doi: 10.1097/00000542-200110000-00009.
PubMed 11605921Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.
PubMed 27317711Brindley PG, Simmonds MR, Needham CJ, Simmonds KA. Teaching airway management to novices: a simulator manikin study comparing the 'sniffing position' and 'win with the chin' analogies. Br J Anaesth. 2010 Apr;104(4):496-500. doi: 10.1093/bja/aeq020. Epub 2010 Feb 18.
PubMed 20167582Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005 Feb;52(2):191-8. doi: 10.1007/BF03027728.
PubMed 15684262El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19.
PubMed 21596871Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
PubMed 2917111Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. No abstract available.
PubMed 20086071Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.
PubMed 20846964Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.
PubMed 20674088Meisami T, Musa M, Keller MA, Cooper R, Clokie CM, Sandor GK. Magnetic resonance imaging assessment of airway status after orthognathic surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Apr;103(4):458-63. doi: 10.1016/j.tripleo.2006.07.006. Epub 2006 Oct 27.
PubMed 17395062Mendonca C, Ungureanu N, Nowicka A, Kumar P. A randomised clinical trial comparing the 'sniffing' and neutral position using channelled (KingVision(R) ) and non-channelled (C-MAC(R) ) videolaryngoscopes. Anaesthesia. 2018 Jul;73(7):847-855. doi: 10.1111/anae.14289. Epub 2018 Apr 16.
PubMed 29660807Stuck BA, Kopke J, Maurer JT, Verse T, Kuciak G, Duber C, Hormann K. Evaluating the upper airway with standardized magnetic resonance imaging. Laryngoscope. 2002 Mar;112(3):552-8. doi: 10.1097/00005537-200203000-00026.
PubMed 12148870
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Magnetic Resonance Imaging Study of Changes in the Angle Between the Tracheal and Laryngeal Axes in the Sniffing, Neutral and Extended Head and Neck Positions for Videolaryngoscopy
- ClinicalTrials.gov ID
- NCT05002790
- Acronym / sponsor ID
- 282078
- Conditions
- Intubation, Intratracheal
- Keywords
- Airway management, Videolaryngoscopy, Hyperangulated blades
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The traditional method of tracheal intubation requires the insertion of a laryngoscope into the oral cavity and directly visualisation of the glottis. The traditional head position called the sniffing the morning air position; consisting of lower cervical flexion and extension of the atlanto-occipital joint is commonly used to facilitate tracheal intubation in this manner by aligning the oral axes and providing the operator a view of the glottis.
With the advancement of technology, has seen videolaryngoscopes (VL) developed to ease tracheal intubation. With VL, the glottis is seen through a camera connected to a viewing screen either attached to the top of the laryngoscope or connected to a camera screen by cable. One of the main drawbacks with VL is that a good view of the glottis is seen on the screen, but it can be difficult to pass the tracheal tube through the glottis in comparison to the traditional intubation technique described above. One of the main factors the authors suggest is that VL-assisted intubation requires a head and neck position that is different to the sniffing the morning air position.
This study aims to assess the oral axes in three different head and neck positions under MRI to assess which positions improve axial alignment the most.
Detailed description
The traditional method of tracheal intubation requires the insertion of a laryngoscope with the left hand into the oral cavity to displace the tongue and directly visualise the glottis.
The sniffing the morning air (or sniffing) position has been traditionally used for tracheal intubation using direct laryngoscopy. This comprises of flexion of the lower cervical spine, extension at the atlanto-occiptal joint and a horizontal level between the tragus of the ear and sternum. The theoretical purpose of this position is to improve the glottic visualisation by aligning the oral, pharyngeal and tracheal axes.
In recent years with the advancement of technology, videolaryngoscopy has become popular and many centres are now using only videolaryngoscopes for tracheal intubation. Visualisation occurs indirectly through fibreoptic or digital channels. Most videolaryngoscopes use two types of blades. The Macintosh type for normal airway and hyper-angulated blade for difficult airway.
Hyperangulated blades such as the Glidescope LoPro (Verathon Inc, Bothwell, WA, USA), McGrath Series 5 X blade (Medtronic, Minneapolis, MN, USA) and Storz C-Mac D-blade (Karl Storz Endoscoke, Tuttlingen, Germany) are more curved than the traditional standard geometry used with direct laryngoscopy and are thought to improve glottis visualisation without significant change in head position. However, visualisation of glottis is one of the three steps involved in videolaryngoscopy assisted tracheal intubation. The other two steps include aligning the tube with the glottic inlet and advancing the tube through the glottis into the trachea.
One of the main drawbacks in videolaryngoscopy is that despite good view of glottis on the screen, it can be difficult to successfully advance the tracheal tube into the trachea. Anterior impingement of the tracheal tube at the sub-glottic region is a recognised problem with hyperangulated and channelled videolaryngoscopes. VL directs the pre-formed tracheal tube anteriorly but the trachea descends posteriorly into the thorax creating an acute angle impeding passage of the tube. This can result in difficult intubation or a failed intubation. Manoeuvres such as tube rotation and rotation of bougie can rectify this problem to some extent.
A previous study found that laryngoscopy was more difficult with hyper-angulated blades in the sniffing position as compared to neutral position, contradictory to traditional laryngoscopy teaching. Intermediary positions between sniffing and supine should be studied as these may balance the needs of maintaining sufficient mouth opening and not hindering angles affecting the axial alignment. Both studies recommend the benefits of a ramped position as it does reduce the time to desaturation and reduces aspiration risk compared to supine neutral positions and should be considered when using hyperangulated blades. .
Using magnetic resonance imaging in awake and healthy patients, Adnet, et al. measured the oral, pharyngeal and tracheal axes using the neutral position, sniffing position and simple head extension and found neither position resulted in perfect alignment of the 3 axes. However, they did not study the effect of position on angle between tracheal and laryngeal axes. The search for further evidence is necessary for VL as there is a paucity of research in with regard to best head and neck position for videolaryngoscopy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment Controlled trial without randomisation
| Arm | Type | Receives |
|---|---|---|
| Data collection | Experimental | Diagnostic Test: Data collection groupAll 20 anticipated subjects to be scanned under MRI, with data collected and analysed together |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide consent
- Volunteers, UHCW staff, aged > 18 years
- Medically able and willing undertake MRI scanning.
- Should pass the MRI safety check list to enter the MRI suite. All participants will complete an MR safety questionnaire immediately prior to their MR scan
Key exclusion criteria (4 listed)
- Unable to provide consent
- Not willing to have MRI scan or unable to undergo MRI scanning
- Known difficult intubation, Restricted or neck extension not possible or presence of arthritis of cervical spine.
- For MRI safety reasons all participants with a cardiac pacemaker or other electronic implants will be excluded from 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 |
|---|---|---|
| Data collection groupMagnetic resonance imaging (MRI) allows measurement of the axes described to suggest which head and neck position would provide best anatomical alignment to reduce anterior impingement. All the MRI scans will be conducted using 3.0 Tesla (Optima 750w, GE Medical, Milwaukee, WI, USA) using the cervical spine section of the coil. T2-weighted images in the sagittal plane will be acquired using a fast recovery fast spin echo (FRFSE) technique. The scans will take around two and half minutes and a member of the anaesthetic investigator team will be present to facilitate positional changes and maintain consistency. MRI scanning will be performed in following 3 head and neck positions: Neutral position, Sniffing position and the Extension position. | Diagnostic test | Data collection |
Primary outcome
Angle A Measured on MRI
Time frame: Each subject will undergo 3 MRI scans. Angle A will be measured on each scan at the end of all the scans performed that day. The angles will be measured by 2 investigators.
To determine which patient head and neck positioning significantly improves the angle A. It is defined as the angle between the tracheal axis (TA) and laryngeal axis (LA)
1 secondary outcome
Angle B, C, D and E Measured Using MRI
Time frame: Each subject will undergo 3 MRI scans. The angles will be measured on each scan at the end of the scanning performed that day. The angles will be measured by 2 investigators.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20116709Abramson ZR, Susarla S, Tagoni JR, Kaban L. Three-dimensional computed tomographic analysis of airway anatomy. J Oral Maxillofac Surg. 2010 Feb;68(2):363-71. doi: 10.1016/j.joms.2009.09.086. Epub 2010 Jan 15.
- Background: PubMed 11135726Adnet F, Borron SW, Dumas JL, Lapostolle F, Cupa M, Lapandry C. Study of the "sniffing position" by magnetic resonance imaging. Anesthesiology. 2001 Jan;94(1):83-6. doi: 10.1097/00000542-200101000-00017.
- Background: PubMed 11605921Adnet F, Baillard C, Borron SW, Denantes C, Lefebvre L, Galinski M, Martinez C, Cupa M, Lapostolle F. Randomized study comparing the "sniffing position" with simple head extension for laryngoscopic view in elective surgery patients. Anesthesiology. 2001 Oct;95(4):836-41. doi: 10.1097/00000542-200110000-00009.
- Background: PubMed 27317711Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.
- Background: PubMed 20167582Brindley PG, Simmonds MR, Needham CJ, Simmonds KA. Teaching airway management to novices: a simulator manikin study comparing the 'sniffing position' and 'win with the chin' analogies. Br J Anaesth. 2010 Apr;104(4):496-500. doi: 10.1093/bja/aeq020. Epub 2010 Feb 18.
- Background: PubMed 15684262Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005 Feb;52(2):191-8. doi: 10.1007/BF03027728.
- Background: PubMed 21596871El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19.
- Background: PubMed 2917111Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
- Background: PubMed 20086071Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. No abstract available.
- Background: PubMed 20846964Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.
- Background: PubMed 20674088Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.
- Background: PubMed 17395062Meisami T, Musa M, Keller MA, Cooper R, Clokie CM, Sandor GK. Magnetic resonance imaging assessment of airway status after orthognathic surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Apr;103(4):458-63. doi: 10.1016/j.tripleo.2006.07.006. Epub 2006 Oct 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection group in people with Intubation, Intratracheal, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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 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 28 Aug 2024. 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 Kingdom. 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 28 Aug 2024). 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?
Angle A Measured on MRI (time frame: Each subject will undergo 3 MRI scans. Angle A will be measured on each scan at the end of all the scans performed that day. The angles will be measured by 2 investigators.). 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 NCT05002790, which also lists 14 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 28 Aug 2024.