Viewing Study NCT06258954



Ignite Creation Date: 2024-05-06 @ 8:06 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06258954
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-02-14
First Post: 2024-01-28

Brief Title: Effect of 3D-printed Reconstruction System in Size of Left DLT
Sponsor: Sichuan Cancer Hospital and Research Institute
Organization: Sichuan Cancer Hospital and Research Institute

Study Overview

Official Title: Effect of 3D-printed Reconstruction Automated Matching System in Selecting the Size of Left Double-lumen Tube
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-02
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 precise and accurate size of DLT is a prerequisite to ensure its accurate position of its placement Three-dimensional 3D reconstruction technology can accurately reproduce the tracheobronchial structure to improve the correct size selection of DLT To make it simpler the investigators developed an automatic comparison software for 3D reconstruction based on computed tomography data 3DRACS In this study the investigators aimed to prove that 3DRACS is much more efficient in endobronchial intubation compared to the traditional method
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 isolationCurrently There is lack of proper objective criteria for selecting size of DLT DLT size selection is estimated empirically using the patients height and sex and studies have shown that the size of DLT according CT images of the chest is more accurate than experience The investigators 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 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

Study Oversight

Has Oversight DMC: None
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?: None
Is an FDA AA801 Violation?: None