- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06236971
Effect of Lateral Positions on the Shape of Upper Airway
Effect of Lateral Positions on the Shape of Upper Airway Under Sedation
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hui Ye, M.D.
- Phone Number: 15267048716
- Email: yehui@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- Tongde Hospital of Zhejiang Province
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Contact:
- Hui Ye, M.D.
- Phone Number: 15267048716
- Email: yehui@zju.edu.cn
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Principal Investigator:
- Xiangming Fang, M.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Magnetic resonance imaging was used to scan the upper airway of sedated subjects, first at supine position and then turn into lateral position.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimum cross-sectional area (MCSA)
Time Frame: through study completion, an average of 2 months
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minimum cross-sectional area (MCSA) of upper airway-related sagittal, cross-sectional, and coronal planes
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through study completion, an average of 2 months
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minimum anteroposterior
Time Frame: through study completion, an average of 2 months
|
minimum anteroposterior diameters
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through study completion, an average of 2 months
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lateral diameters
Time Frame: through study completion, an average of 2 months
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lateral diameters
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through study completion, an average of 2 months
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pharyngeal volume
Time Frame: through study completion, an average of 2 months
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pharyngeal volume
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through study completion, an average of 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
three-dimensional geometrical modeling of the upper airway
Time Frame: through study completion, an average of 2 months
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three-dimensional geometrical modeling of the upper airway by MATALAB software
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through study completion, an average of 2 months
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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
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compared the change of HR in beats per minute between different position
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before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
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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
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compared the change of SpO2 (%)
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before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
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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
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compared the change of RR in respirations per minute between different position
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before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xiangming Fang, M.D., The First Affiliated Hospital School of MedicineZhejiang University
Publications and helpful links
General Publications
- Litman 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.
- 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.
- Campos 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.
- Chen 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.
- Martinez 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.
- Dollinger 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.
- Li 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.
- Hyldmo 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.
- Litman 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- airway
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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