Clinical trial NCT06258954: Effect of 3D-printed Reconstruction System in Size of Left DLT
Official title: Effect of 3D-printed Reconstruction Automated Matching System in Selecting the Size of Left Double-lumen Tube
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer of Lung
Lung Isolation
Keywords: Lung isolation
double-lumen tube
Three-dimensional reconstruction
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: the success rates of placement of left DLT without FOB
timeFrame: After intubation，an average of 2 hours
Secondary outcomes:
measure: The time of completing the left DLT's position
timeFrame: After intubation，an average of 2 hours
measure: The number of the patients who need to change the size of the left DLT
timeFrame: After intubation，an average of 2 hours
measure: Appropriate standard for the left DLT
timeFrame: After intubation，an average of 2 hours
measure: Lung collapse
timeFrame: At 10 and 20 minute after pleurotomy
measure: Grading of the airway injury
timeFrame: After extubation，an average of 1 hours
measure: Postoperative sore throat and hoarseness
timeFrame: 1, 2 days after surgery
measure: Oxygenation during one-lung ventilation
timeFrame: At the end of surgery.
measure: Times of using FOB
timeFrame: At the end of surgery.
Other outcomes:
Locations:
Study officials:
affiliation: department of anesthesiology, sichuan cancer hospital
name: Yihao Zhu, master
role: PRINCIPAL_INVESTIGATOR
References: