Clinical Trials Directory

Trials / Completed

CompletedNCT06839261

Evaluation of Double Lumen Tube Intubation Difficulty With Photo-Based Artificial Intelligence Algorithms

Efficacy and Reliability of Photo-Based Artificial Intelligence Algorithms in Assessing Difficulty of Intubation With a Double-Lumen Tube

Status
Completed
Phase
Study type
Observational
Enrollment
260 (actual)
Sponsor
Ankara Ataturk Sanatorium Training and Research Hospital · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The complexity and difficulty of intubation with double lumen tubes requires the use of advanced technologies in the management of this procedure. The potential of photo-based artificial intelligence algorithms to predict and minimize the difficulties encountered during intubation is the main motivation for this study. The utilization of artificial intelligence algorithms within the domain of airway management holds considerable promise in providing real-time feedback to anesthesiologists, enhancing the efficacy of intubation procedures, and reducing the occurrence of complications. Specifically, photo-based AI systems can facilitate a more comprehensive understanding of airway anatomy by analyzing images captured prior to and during intubation, thereby enhancing the management of complex cases.The objective of this study is to examine the efficacy and reliability of photo-based artificial intelligence algorithms in evaluating the complexity of intubation with a double lumen tube.The integration of artificial intelligence into the intubation process is intended to enhance patient outcomes and establish a new benchmark for anesthesia practice. This study aims to address the existing gap in the literature and provide innovative approaches to clinical practice. Informed consent was obtained from patients undergoing thoracic surgery operations, and demographic data (age, height, body weight, body mass index, gender), American Society of Anesthesiologists (ASA) score, type of operation, and comorbid diseases (diabetes mellitus, hypertension, coronary artery disease, chronic kidney disease, chronic obstructive pulmonary disease, asthma, obstructive sleep apnea) were obtained. Thoracic and/or extrath oracic malignancy history), parameters considered as risk factors for difficult intubation (history of previous difficult intubation, LEMON criteria (look externally, evaluate, mallampathy, obstruction, neck mobility), upper lip bite test) and photographs of the patients (including head and neck region) will be recorded in six different directions and ways with a professional camera (actively used in our hospital) in the preoperative period. During the intraoperative phase, the Cormack-Lehane scoring system will be employed, and the intubation process with a double-lumen tube will be evaluated for ease or difficulty. Intraoperative complications related to the operation will also be documented.The data will then be processed using Python 3 programming language and open-source libraries to calculate artificial intelligence algorithms. In the event of incomplete patient data, data imputation techniques will be employed to supplement the artificial intelligence program. The primary outcome variable of the study is the rate at which the photo-based artificial intelligence algorithm predicts whether intubation with a double lumen tube is easy or difficult.The secondary outcome variable is the comparison of the rate of prediction of intubation with double lumen tube by photo-based artificial intelligence algorithms and the rate of prediction of intubation with double lumen tube by conventional methods.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTIntubation Difficulty ScaleThe Intubation Difficulty Scale (IDS) is an objective way to classify easy and difficult intubation. A score ≤ 5 indicates an easy or mildly difficult intubation, while IDS \> 5 suggests difficult intubation, requiring additional techniques or attempts.
OTHERArtificial IntelligenceThe program made with Python 3 programming language using open source libraries. It will be developed to predict difficult intubation with 6 different photo data of patients, this process will be taught with a learning process and then tested.

Timeline

Start date
2024-12-01
Primary completion
2025-03-01
Completion
2025-03-30
First posted
2025-02-21
Last updated
2025-09-08

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06839261. Inclusion in this directory is not an endorsement.