Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 6:32 PM
Study NCT ID:
NCT06839261
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2025-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Double Lumen Tube Intubation Difficulty With Photo-Based Artificial Intelligence Algorithms
Sponsor:
Ankara Ataturk Sanatorium Training and Research Hospital
Organization:
Study Overview
Official Title:
Efficacy and Reliability of Photo-Based Artificial Intelligence Algorithms in Assessing Difficulty of Intubation With a Double-Lumen Tube
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: