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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer of Lung Lung Isolation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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3D group

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

Group Type EXPERIMENTAL

3D reconstruction

Intervention Type OTHER

3D reconstruction based on CT data and It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size of the DLT for lung isolation.

control group

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

Group Type PLACEBO_COMPARATOR

traditional method for selecting double lumen tube

Intervention Type OTHER

In control group, the size of DLT is based on patient's sex and height.

Interventions

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3D reconstruction

3D reconstruction based on CT data and It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size of the DLT for lung isolation.

Intervention Type OTHER

traditional method for selecting double lumen tube

In control group, the size of DLT is based on patient's sex and height.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No