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NCT Number: NCT06270797

Pre-anesthesia Imaging-based Respiratory Assessment and Analysis

This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 80756, Taiwan

Location status: Recruiting

Location contact

Tz Ping Gau, MD

CONTACT

[email protected]

+886912060962

About this study

Anesthesia respiratory assessment is an important issue for anesthesiologists to evaluate the respiratory status and airway management of patients before surgery. The American Society of Anesthesiologists (ASA) updated its guidelines in 2022, emphasizing the importance of comprehensive respiratory assessment in the guidelines.

Various risk factors have been proposed in past literature for discussion, and corresponding to these risk factors, there is currently no single factor that can predict difficult intubation completely. Existing investigations into difficult intubation factors mostly focus on high-risk populations, including patients with morbid obesity, where significant differences have been identified but not developed into predictive models.

With the rapid development of AI-related technologies in recent years, numerous image-related AI frameworks have been proposed. In recent years, attempts have been made to combine various clinical risk factors using machine learning methods to create automated prediction models for difficult intubation. However, their effectiveness has not met expectations, reflecting the significant clinical problem of difficulty in prediction that remains unresolved.

This study is an observational study aimed at analyzing and establishing patient image data, refining various data engineering techniques, and optimizing existing prediction model frameworks to enhance their medical value. Additionally, the focus of this project will be on establishing more prediction models to improve existing clinical decision support systems.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing general anesthesia
  • Patients who can undergo pre-anesthetic consultation and airway examination.

Exclusion criteria

  • Patients unable to undergo pre-anesthetic consultation and airway examination.
  • Patients requiring emergency surgery.
  • Vulnerable populations.

Treatment and study plan

intubation for general anesthesia

Procedure

routine intubation for general anesthesia

Primary outcomes

  1. A pre-anesthesia evaluation

    Time frame: pre-anesthetic consultation about 20 min

    The examination includes airway assessment and dental evaluation.

  2. Perform non-invasive imaging capture.

    Time frame: pre-anesthetic consultation about 5 min

    The capture involves non-invasive imaging of the patient's facial features through standard basic photography, excluding any additional radiographic imaging examinations.The patient's images will be stored in de-identified form.

  3. difficult intubation prediction

    Time frame: after pre-anesthetic consultation about 5 min

    The prediction of difficult intubation from pre-anesthesia evaluation and non-invasive imaging capture

Secondary outcomes

  1. time to successfully extubate the nasotracheal tube after anesthesia

    Time frame: from the end of surgery to the post-anesthesia care, assessed up to one hour

    early extubation allowable

  2. safely discharged from post-anesthesia care unit (postoperative recovery room)

    Time frame: 2 hours

    as calculating the time from patient is delivered to postoperative recovery room to be safely discharged from recovery room by using the aldrete scores (activities level, respiration, circulation, conscious level, oxygenation) full back to pre-operative level or ten scores.

  3. side effects and adverse events

    Time frame: intraoperative and postoperative stages, assessed up to 48 hours

    records any abnormal surgical or anesthesia related findings during this admission

Study contacts

Contact information is provided by the study sponsor or research team.

Kuang-I Cheng, MD,Phd

CONTACT

[email protected]

+886975357568

Tz Ping Gau, MD

CONTACT

[email protected]

+886912060962

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Feb 21, 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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