Effect of 3D-printed Reconstruction System in Size of Left DLT

University of Electronic Science and Technology of China (UESTC)

Status: Not yet enrolling

Conditions: Lung Isolation; Cancer of Lung

Treatments: Other: traditional method for selecting double lumen tube; Other: 3D reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT06258954

scchec-20240128

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 75 years.
2. American Society of Anesthesiologists Physical Status (ASA-PS) I-III.
3. Planned to receive lung resection surgery during lung isolation techniques by using DLT.
4. Signed informed written consent.

Exclusion criteria

The participant experiences any of the following：

1. Spinal malformation,
2. Expected difficult airway
3. Tracheal stenosis
4. Tracheal tumor
5. Bronchial tumor
6. Distorted airway anatomy
7. Tumors of the mouth or neck

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

3D group

Experimental group

Description:

Using automatic comparison software for 3D reconstruction to determine the size of DLT.

Treatment:

Other: 3D reconstruction

control group

Placebo Comparator group

Description:

The size of DLT is based on patient's sex and height.

Treatment:

Other: traditional method for selecting double lumen tube