Clinical trial NCT05899270: 3D-printed Reconstruction Automated Matching System Predicts Size of Double-lumen Tube: a Prospective Double-blinded Randomized Controlled Trial
Official title: Effect of 3D-printed Reconstruction Automated Matching System in Size Selection of Double-lumen Tube：a Prospective Double-blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lung Diseases
Tracheal Intubation Morbidity
Throat Injury
Bronchus; Injury
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Science and Technology Department of Sichuan Province
First posted: 2023-06-12
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
Intervention model description: Participates recruited from Sichuan Cancer Hospital will randomized to 3D group and control group in 1:1 ratio via a random number list generated by a computer.
Primary purpose: TREATMENT

Brief summary: Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients. We 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 and depth 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.

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. we 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 and depth 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: Incidence of correct endobronchial intubation.
timeFrame: after intubation
Secondary outcomes:
measure: Time to successful intubation
timeFrame: after intubation
measure: Degree of pulmonary atrophy
timeFrame: after surgery begin
measure: Grading of airway injury
timeFrame: When extubation
measure: Postoperative sore throat and hoarseness
timeFrame: At 1 hour and 24 hours after extubation
measure: Oxygenation during one-lung ventilation
timeFrame: Intraoperative（from beginning of one lung ventilation to end），an average of 2 hours
measure: Account times of using FOB
timeFrame: During surgery (from induction to extubation), an average of 3 hour
Other outcomes:
Locations:
Study officials:
affiliation: department of anesthesiology, sichuan cancer hospital
name: Yihao Zhu, master
role: PRINCIPAL_INVESTIGATOR
References: