Airway RemodelingNCT06236971
Effect of Lateral Positions on the Shape of Upper Airway
An observational study of Airway Remodeling and Radiography in Otolaryngology, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The severity and frequency of respiratory events is increased in the supine body posture compared with the lateral position in emergency, difficult airway patients. The mechanism responsible is not clear but may relate to the effect of position on upper airway shape and size. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Remodeling, Radiography in Otolaryngology, Position
- What is being tested?
- MRI scanning first at supine position and then turn into lateral position
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 29 Mar 2024
- Phase
- Observational
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects aged over 18 years old, ASA 1~II without serious cardiopulmonary disease, scheduled for magnetic resonance imaging scan in the supine position and followed lateral position at a tertiary hospital from January 2024 to February 2024 were enrolled in this study.
Who may be able to join
- Subjects aged over than 18 years and less than 100 years
- The American Society of Anesthesiologists (ASA) score was grade I to II
- There was no serious cardiopulmonary disease
Who cannot join
- Unable to maintain oxygenation before or during the examination and requiring intervention
- Those with preoperative arrhythmia requiring intervention
- Thosewith severe hematological diseases, severe metabolic diseases, severe liver and kidney organ insufficiency
- Those do not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lateral Positions on the Shape of Upper Airway Under Sedation
The severity and frequency of respiratory events is increased in the supine body posture compared with the lateral position in emergency, difficult airway patients. The mechanism responsible is not clear but may relate to the effect of position on upper airway shape and size. 3D finite element model of upper airway filling based on MRI image reconstruction can effectively reflect the anatomy of the upper airway. This study compared the effect of body position on upper airway shape and size in individuals with lateral position among sedated subjects.
Read the detailed description
Anesthesiologists may encounter situations in which a accidental loss of airway patency occurs in patients in a lateral patient position during surgery. Intubation is required in the lateral position in cases of oropharyngeal bleeding to reduce the risk of aspiration, or in airway management in some patients with limited posture. The severity and frequency of respiratory events is increased in the supine body posture compared with the lateral position in emergency, difficult airway patients. The mechanism responsible is not clear but may relate to the effect of position on upper airway shape and size secondary to gravitational effects. Lateral positioning decreases upper airway obstruction in sleeping individuals, children breathing spontaneously, and adults during general anesthesia. The mechanical upper airway properties may become the dominant factor governing upper airway collapsibility during sedation due to the significant depression of consciousness and the impairment of neural mechanisms controlling compensatory neuromuscular responses. Anesthesiologists and surgeons who are responsible for airway management during procedures under sedation and the perioperative period should be well versed with the physiological and pathophysiological mechanisms affecting upper airway patency. 3D finite element model of upper airway filling based on MRI image reconstruction can effectively reflect the anatomy of the upper airway.
The primary aim of this study was to determine the changes in upper airway shape and size that occur when sedated, spontaneously breathing adults are placed in the lateral position. These findings may provide new guidance for the evaluation and prediction of difficult airway during clinical anesthesia.
- Conditions
- Airway Remodeling, Radiography in Otolaryngology, Position, Patency, Morphology
- Being tested
- MRI scanning first at supine position and then turn into lateral position
- Medical subject headings
- Airway Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanning first at supine position and then turn into lateral positionBehavioural
Magnetic resonance imaging was used to scan the upper airway of sedated subjects, first at supine position and then turn into lateral position.
| Study group | Role | What they receive |
|---|---|---|
| MRI scanning | The subjects are receiving MRI scanning first in the supine position, and then in the lateral position. The field of view was determined from the length and girth of each patient's head, at least including the skull base to the level of tracheal bifurcation. Receives: Behavioral: MRI scanning first at supine position and then turn into lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimum cross-sectional area (MCSA)
minimum cross-sectional area (MCSA) of upper airway-related sagittal, cross-sectional, and coronal planes
Measured: through study completion, an average of 2 months
minimum anteroposterior
minimum anteroposterior diameters
Measured: through study completion, an average of 2 months
lateral diameters
lateral diameters
Measured: through study completion, an average of 2 months
pharyngeal volume
pharyngeal volume
Measured: through study completion, an average of 2 months
Secondary outcomes (4)
three-dimensional geometrical modeling of the upper airway
three-dimensional geometrical modeling of the upper airway by MATALAB software
Measured: through study completion, an average of 2 months
Change of heart rates (HR) in beats per minute
compared the change of HR in beats per minute between different position
Measured: before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
Change of oxygenation (SpO2, %)
compared the change of SpO2 (%)
Measured: before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
Change of respiratory rates (RR) in respirations per minute
compared the change of RR in respirations per minute between different position
Measured: before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start5 Feb 2024
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Airway RemodelingStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Responsible party
- Principal investigator, xiangming fang, First Affiliated Hospital of Zhejiang University
- Investigators
- Xiangming Fang, M.D., Principal investigator, The First Affiliated Hospital School of MedicineZhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236971
- Sponsor's protocol ID
- airway
- Status last verified
- May 2024
- First submitted
- 13 Jan 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin CY, Chen CN, Kang KT, Hsiao TY, Lee PL, Hsu WC. Ultrasonographic Evaluation of Upper Airway Structures in Children With Obstructive Sleep Apnea. JAMA Otolaryngol Head Neck Surg. 2018 Oct 1;144(10):897-905. doi: 10.1001/jamaoto.2018.1809.
PubMed 30242332Campos LD, Trindade IEK, Trindade SHK, Pimenta LAF, Kimbell J, Drake A, Marzano-Rodrigues MN, Trindade-Suedam IK. Effects of 3D Airway Geometry on the Airflow of Adults with Cleft Lip and Palate and Obstructive Sleep Apnea: A Functional Imaging Study. Sleep Sci. 2023 Nov 22;16(4):e430-e438. doi: 10.1055/s-0043-1776868. eCollection 2023 Dec.
PubMed 38197022Chen W, Ma L, Shao J, Bi C, Xie Y, Zhao S. Morphological specificity analysis of an image-based 3D model of airway filling in a difficult airway. BMC Anesthesiol. 2022 Nov 3;22(1):336. doi: 10.1186/s12871-022-01880-6.
PubMed 36329383Martinez A, Muniz AL, Soudah E, Calvo J, Suarez AA, Cobo J, Cobo T. Physiological and geometrical effects in the upper airways with and without mandibular advance device for sleep apnea treatment. Sci Rep. 2020 Mar 24;10(1):5322. doi: 10.1038/s41598-020-61467-4.
PubMed 32210246Dollinger M, Jakubass B, Cheng H, Carter SJ, Kniesburges S, Aidoo B, Lee CH, Milstein C, Patel RR. Computational fluid dynamics of upper airway aerodynamics for exercise-induced laryngeal obstruction: A feasibility study. Laryngoscope Investig Otolaryngol. 2023 Aug 19;8(5):1294-1303. doi: 10.1002/lio2.1140. eCollection 2023 Oct.
PubMed 37899858Li H, Wang W, Lu YP, Wang Y, Chen LH, Lei LP, Fang XM. Evaluation of Endotracheal Intubation with a Flexible Fiberoptic Bronchoscope in Lateral Patient Positioning: A Prospective Randomized Controlled Trial. Chin Med J (Engl). 2016 Sep 5;129(17):2045-9. doi: 10.4103/0366-6999.189069.
PubMed 27569229Hyldmo PK, Vist GE, Feyling AC, Rognas L, Magnusson V, Sandberg M, Soreide E. Is the supine position associated with loss of airway patency in unconscious trauma patients? A systematic review and meta-analysis. Scand J Trauma Resusc Emerg Med. 2015 Jul 1;23:50. doi: 10.1186/s13049-015-0116-0.
PubMed 26129809Litman RS, Wake N, Chan LM, McDonough JM, Sin S, Mahboubi S, Arens R. Effect of lateral positioning on upper airway size and morphology in sedated children. Anesthesiology. 2005 Sep;103(3):484-8. doi: 10.1097/00000542-200509000-00009.
PubMed 16129971Litman RS, Weissend EE, Shrier DA, Ward DS. Morphologic changes in the upper airway of children during awakening from propofol administration. Anesthesiology. 2002 Mar;96(3):607-11. doi: 10.1097/00000542-200203000-00016.
PubMed 11873035
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lateral Positions on the Shape of Upper Airway Under Sedation
- ClinicalTrials.gov ID
- NCT06236971
- Acronym / sponsor ID
- airway
- Conditions
- Airway Remodeling, Radiography in Otolaryngology, Position, Patency, Morphology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- 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.
The severity and frequency of respiratory events is increased in the supine body posture compared with the lateral position in emergency, difficult airway patients. The mechanism responsible is not clear but may relate to the effect of position on upper airway shape and size. 3D finite element model of upper airway filling based on MRI image reconstruction can effectively reflect the anatomy of the upper airway. This study compared the effect of body position on upper airway shape and size in individuals with lateral position among sedated subjects.
Detailed description
Anesthesiologists may encounter situations in which a accidental loss of airway patency occurs in patients in a lateral patient position during surgery. Intubation is required in the lateral position in cases of oropharyngeal bleeding to reduce the risk of aspiration, or in airway management in some patients with limited posture. The severity and frequency of respiratory events is increased in the supine body posture compared with the lateral position in emergency, difficult airway patients. The mechanism responsible is not clear but may relate to the effect of position on upper airway shape and size secondary to gravitational effects. Lateral positioning decreases upper airway obstruction in sleeping individuals, children breathing spontaneously, and adults during general anesthesia. The mechanical upper airway properties may become the dominant factor governing upper airway collapsibility during sedation due to the significant depression of consciousness and the impairment of neural mechanisms controlling compensatory neuromuscular responses. Anesthesiologists and surgeons who are responsible for airway management during procedures under sedation and the perioperative period should be well versed with the physiological and pathophysiological mechanisms affecting upper airway patency. 3D finite element model of upper airway filling based on MRI image reconstruction can effectively reflect the anatomy of the upper airway.
The primary aim of this study was to determine the changes in upper airway shape and size that occur when sedated, spontaneously breathing adults are placed in the lateral position. These findings may provide new guidance for the evaluation and prediction of difficult airway during clinical anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scanning | – | Behavioral: MRI scanning first at supine position and then turn into lateral positionThe subjects are receiving MRI scanning first in the supine position, and then in the lateral position. The field of view was determined from the length and girth of each patient's head, at least including the skull base to the level of tracheal bifurcation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects aged over 18 years old, ASA 1~II without serious cardiopulmonary disease, scheduled for magnetic resonance imaging scan in the supine position and followed lateral position at a tertiary hospital from January 2024 to February 2024 were enrolled in this study.
Key inclusion criteria (3 listed)
- Subjects aged over than 18 years and less than 100 years
- The American Society of Anesthesiologists (ASA) score was grade I to II
- There was no serious cardiopulmonary disease
Key exclusion criteria (4 listed)
- Unable to maintain oxygenation before or during the examination and requiring intervention
- Those with preoperative arrhythmia requiring intervention
- Thosewith severe hematological diseases, severe metabolic diseases, severe liver and kidney organ insufficiency
- Those do not consent to participate in 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 |
|---|---|---|
| MRI scanning first at supine position and then turn into lateral positionMagnetic resonance imaging was used to scan the upper airway of sedated subjects, first at supine position and then turn into lateral position. | Behavioural | MRI scanning |
Primary outcome
minimum cross-sectional area (MCSA)
Time frame: through study completion, an average of 2 months
minimum cross-sectional area (MCSA) of upper airway-related sagittal, cross-sectional, and coronal planes
minimum anteroposterior
Time frame: through study completion, an average of 2 months
minimum anteroposterior diameters
lateral diameters
Time frame: through study completion, an average of 2 months
lateral diameters
pharyngeal volume
Time frame: through study completion, an average of 2 months
pharyngeal volume
4 secondary outcomes
three-dimensional geometrical modeling of the upper airway
Time frame: through study completion, an average of 2 months
Change of heart rates (HR) in beats per minute
Time frame: before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
Change of oxygenation (SpO2, %)
Time frame: before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
Change of respiratory rates (RR) in respirations per minute
Time frame: before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
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 28 May 2024.
- Background: PubMed 30242332Lin CY, Chen CN, Kang KT, Hsiao TY, Lee PL, Hsu WC. Ultrasonographic Evaluation of Upper Airway Structures in Children With Obstructive Sleep Apnea. JAMA Otolaryngol Head Neck Surg. 2018 Oct 1;144(10):897-905. doi: 10.1001/jamaoto.2018.1809.
- Background: PubMed 38197022Campos LD, Trindade IEK, Trindade SHK, Pimenta LAF, Kimbell J, Drake A, Marzano-Rodrigues MN, Trindade-Suedam IK. Effects of 3D Airway Geometry on the Airflow of Adults with Cleft Lip and Palate and Obstructive Sleep Apnea: A Functional Imaging Study. Sleep Sci. 2023 Nov 22;16(4):e430-e438. doi: 10.1055/s-0043-1776868. eCollection 2023 Dec.
- Background: PubMed 36329383Chen W, Ma L, Shao J, Bi C, Xie Y, Zhao S. Morphological specificity analysis of an image-based 3D model of airway filling in a difficult airway. BMC Anesthesiol. 2022 Nov 3;22(1):336. doi: 10.1186/s12871-022-01880-6.
- Background: PubMed 32210246Martinez A, Muniz AL, Soudah E, Calvo J, Suarez AA, Cobo J, Cobo T. Physiological and geometrical effects in the upper airways with and without mandibular advance device for sleep apnea treatment. Sci Rep. 2020 Mar 24;10(1):5322. doi: 10.1038/s41598-020-61467-4.
- Background: PubMed 37899858Dollinger M, Jakubass B, Cheng H, Carter SJ, Kniesburges S, Aidoo B, Lee CH, Milstein C, Patel RR. Computational fluid dynamics of upper airway aerodynamics for exercise-induced laryngeal obstruction: A feasibility study. Laryngoscope Investig Otolaryngol. 2023 Aug 19;8(5):1294-1303. doi: 10.1002/lio2.1140. eCollection 2023 Oct.
- Background: PubMed 27569229Li H, Wang W, Lu YP, Wang Y, Chen LH, Lei LP, Fang XM. Evaluation of Endotracheal Intubation with a Flexible Fiberoptic Bronchoscope in Lateral Patient Positioning: A Prospective Randomized Controlled Trial. Chin Med J (Engl). 2016 Sep 5;129(17):2045-9. doi: 10.4103/0366-6999.189069.
- Background: PubMed 26129809Hyldmo PK, Vist GE, Feyling AC, Rognas L, Magnusson V, Sandberg M, Soreide E. Is the supine position associated with loss of airway patency in unconscious trauma patients? A systematic review and meta-analysis. Scand J Trauma Resusc Emerg Med. 2015 Jul 1;23:50. doi: 10.1186/s13049-015-0116-0.
- Background: PubMed 16129971Litman RS, Wake N, Chan LM, McDonough JM, Sin S, Mahboubi S, Arens R. Effect of lateral positioning on upper airway size and morphology in sedated children. Anesthesiology. 2005 Sep;103(3):484-8. doi: 10.1097/00000542-200509000-00009.
- Background: PubMed 11873035Litman RS, Weissend EE, Shrier DA, Ward DS. Morphologic changes in the upper airway of children during awakening from propofol administration. Anesthesiology. 2002 Mar;96(3):607-11. doi: 10.1097/00000542-200203000-00016.
- 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.
Xiangming Fang, M.D. principal investigator
The First Affiliated Hospital School of MedicineZhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Remodeling and Radiography in Otolaryngology, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 3 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 May 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 China. 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?
minimum cross-sectional area (MCSA) (time frame: through study completion, an average of 2 months). The study lists 4 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 NCT06236971, which also lists 9 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 May 2024.