Effect of Lateral Positions on the Shape of Upper Airway

January 24, 2024 updated by: xiangming fang, First Affiliated Hospital of Zhejiang University

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.

Study Overview

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

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Tongde Hospital of Zhejiang Province
        • Contact:
        • Principal Investigator:
          • Xiangming Fang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
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
Time Frame: through study completion, an average of 2 months
minimum anteroposterior diameters
through study completion, an average of 2 months
lateral diameters
Time Frame: through study completion, an average of 2 months
lateral diameters
through study completion, an average of 2 months
pharyngeal volume
Time Frame: through study completion, an average of 2 months
pharyngeal volume
through study completion, an average of 2 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiangming Fang, M.D., The First Affiliated Hospital School of MedicineZhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 28, 2024

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • airway

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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