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Trial Title:
Effect of 3D-printed Reconstruction System in Size of Left DLT
NCT ID:
NCT06258954
Condition:
Cancer of Lung
Lung Isolation
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung isolation
double-lumen tube
Three-dimensional reconstruction
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
3D reconstruction
Description:
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.
Arm group label:
3D group
Intervention type:
Other
Intervention name:
traditional method for selecting double lumen tube
Description:
In control group, the size of DLT is based on patient's sex and height.
Arm group label:
control group
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 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
July 30, 2024
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06258954
