Pre-anesthesia Imaging-based Respiratory Assessment and Analysis

NCT06270797 | Recruiting DMC

• 1 other identifier: KMUHIRB-E(I)-20230184
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clinical Decision Support System

Keywords

knowledge graph; artificial intelligence; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (3)

• A pre-anesthesia evaluation

  The examination includes airway assessment and dental evaluation.

  pre-anesthetic consultation about 20 min

• Perform non-invasive imaging capture.

  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.

  pre-anesthetic consultation about 5 min

• difficult intubation prediction

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

  after pre-anesthetic consultation about 5 min

Secondary Outcomes (3)

• time to successfully extubate the nasotracheal tube after anesthesia

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

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

  2 hours

• side effects and adverse events

  intraoperative and postoperative stages, assessed up to 48 hours

Study Arms (2)

normal intubation

during general anesthesia, normal intubation without any difficult airway or difficult intubation were recorded in the note.

Procedure: intubation for general anesthesia

difficult airway or difficult intubation

during general anesthesia, any type of difficult airway or difficult intubation were recorded in the note.

Procedure: intubation for general anesthesia

Interventions

intubation for general anesthesia PROCEDURE

routine intubation for general anesthesia

difficult airway or difficult intubation; normal intubation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing regular general anesthesia with pre-anesthetic consultation and airway examination.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 80756, Taiwan

RECRUITING

MeSH Terms

Interventions

Intubation; Anesthesia, General

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Anesthesia; Anesthesia and Analgesia

Study Officials

• Kuang-I Cheng, MD,Phd

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Tz Ping Gau, MD

CONTACT

+886912060962; u9401066@gap.kmu.edu.tw

Kuang-I Cheng, MD,Phd

CONTACT

+886975357568; kuaich@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 21, 2024

Record last verified: 2023-12

Locations

TW (1)