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Completed

NCT Number: NCT06236971

Effect of Lateral Positions on the Shape of Upper Airway

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. minimum anteroposterior

    Time frame: through study completion, an average of 2 months

    minimum anteroposterior diameters

  3. lateral diameters

    Time frame: through study completion, an average of 2 months

    lateral diameters

  4. pharyngeal volume

    Time frame: through study completion, an average of 2 months

    pharyngeal volume

Secondary outcomes

  1. three-dimensional geometrical modeling of the upper airway

    Time frame: through study completion, an average of 2 months

    three-dimensional geometrical modeling of the upper airway by MATALAB software

  2. 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

    compared the change of HR in beats per minute between different position

  3. 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

    compared the change of SpO2 (%)

  4. 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

    compared the change of RR in respirations per minute between different position

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Zhejiang Provincial Tongde Hospital

Registry information

Official study title

Effect of Lateral Positions on the Shape of Upper Airway Under Sedation

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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