NCT05899270

3D-printed Reconstruction Automated Matching System Predicts Size of Double-lumen Tube: a Prospective Double-blinded Randomized Controlled Trial

Effect of 3D-printed Reconstruction Automated Matching System in Size Selection of Double-lumen Tube：a Prospective Double-blinded Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients. We have developed an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation.The aim of this study was to compare whether the use of 3DRACS to select a DLT size compared to conventional empirical selection methods could improve incidence of DLT intubation success and reduce airway injury.

Detailed description

Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients undergoing various intra-thoracic procedures. Lung isolation is primarily accomplished with a double-lumen tube (DLT) or bronchial blocker. One published study showed that residents with limited experience had a 40% error rate in accurately placing a DLT. The accurate choice of the size of DLT is a prerequisite for good lung isolation.Currently, There is lack of proper objective criteria for selecting size of DLT. DLT size selection is estimated empirically using the patient's height and sex, and studies have shown that the size of DLT according CT images of the chest is more accurate than experience. we have developed an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation. The aim of this study was to compare whether the use of 3DRACS to select a DLT size compared to conventional empirical selection methods could improve incidence of DLT intubation success and reduce airway injury.

Conditions

• Lung Cancer
• Lung Diseases
• Tracheal Intubation Morbidity
• Throat Injury
• Bronchus; Injury

Interventions

Type	Name	Description
OTHER	3D reconstruction automatic matching system	it is an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation.
OTHER	traditional method for selecting double lumen tube	In control group, the size of DLT is based on patient's sex and weight and the height is used to guide the depth of DLT insertion.

Timeline

• Start date: 2023-11-01
• Primary completion: 2023-11-30
• Completion: 2024-03-30
• First posted: 2023-06-12
• Last updated: 2023-06-12