Effect of Lateral Positions on the Shape of Upper Airway

NCT06236971 | Completed

• 1 other identifier: airway
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Airway Remodeling; Radiography in Otolaryngology; Position; Patency; Morphology

Outcome Measures

Primary Outcomes (4)

• 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

• minimum anteroposterior

  minimum anteroposterior diameters

  through study completion, an average of 2 months

• lateral diameters

  lateral diameters

  through study completion, an average of 2 months

• pharyngeal volume

  pharyngeal volume

  through study completion, an average of 2 months

Secondary Outcomes (4)

• three-dimensional geometrical modeling of the upper airway

  through study completion, an average of 2 months

• Change of heart rates (HR) in beats per minute

  before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position

• Change of oxygenation (SpO2, %)

  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

  before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position

Study Arms (1)

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.

Behavioral: MRI scanning first at supine position and then turn into lateral position

Interventions

MRI scanning first at supine position and then turn into lateral position BEHAVIORAL

Magnetic resonance imaging was used to scan the upper airway of sedated subjects, first at supine position and then turn into lateral position.

MRI scanning

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Zhejiang Provincial Tongde Hospital: collaborator

Study Sites (1)

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (9)

• 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.

  PMID: 30242332 BACKGROUND

• 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.

  PMID: 38197022 BACKGROUND

• 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.

  PMID: 36329383 BACKGROUND

• 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.

  PMID: 32210246 BACKGROUND

• 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.

  PMID: 37899858 BACKGROUND

• 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.

  PMID: 27569229 BACKGROUND

• 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.

  PMID: 26129809 BACKGROUND

• 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.

  PMID: 16129971 BACKGROUND

• 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.

  PMID: 11873035 BACKGROUND

MeSH Terms

Conditions

Airway Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangming Fang, M.D.

  The First Affiliated Hospital School of MedicineZhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: February 1, 2024
• Study Start: February 5, 2024
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)