Airway Remodeling Clinical Trial
Official title:
Effect of Lateral Positions on the Shape of Upper Airway Under Sedation
NCT number | NCT06236971 |
Other study ID # | airway |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 5, 2024 |
Est. completion date | March 29, 2024 |
Verified date | May 2024 |
Source | First Affiliated Hospital of Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | March 29, 2024 |
Est. primary completion date | March 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Subjects aged over than 18 years and less than 100 years 2. The American Society of Anesthesiologists (ASA) score was grade I to II 3. There was no serious cardiopulmonary disease Exclusion Criteria: 1. Unable to maintain oxygenation before or during the examination and requiring intervention 2. Those with preoperative arrhythmia requiring intervention 3. Thosewith severe hematological diseases, severe metabolic diseases, severe liver and kidney organ insufficiency 4. Those do not consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
China | Tongde Hospital of Zhejiang Province | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University | Zhejiang Provincial Tongde Hospital |
China,
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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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | minimum cross-sectional area (MCSA) | minimum cross-sectional area (MCSA) of upper airway-related sagittal, cross-sectional, and coronal planes | through study completion, an average of 2 months | |
Primary | minimum anteroposterior | minimum anteroposterior diameters | through study completion, an average of 2 months | |
Primary | lateral diameters | lateral diameters | through study completion, an average of 2 months | |
Primary | pharyngeal volume | pharyngeal volume | through study completion, an average of 2 months | |
Secondary | three-dimensional geometrical modeling of the upper airway | three-dimensional geometrical modeling of the upper airway by MATALAB software | through study completion, an average of 2 months | |
Secondary | Change of heart rates (HR) in beats per minute | compared the change of HR in beats per minute between different position | before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position | |
Secondary | Change of oxygenation (SpO2, %) | compared the change of SpO2 (%) | before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position | |
Secondary | Change of respiratory rates (RR) in respirations per minute | compared the change of RR in respirations per minute between different position | before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position |
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