3D-printed Reconstruction Automated Matching System Predicts Size of Double-lumen Tube: a Prospective Double-blinded Randomized Controlled Trial

Effect of 3D-printed Reconstruction Automated Matching System in Size Selection of Double-lumen Tube：a Prospective Double-blinded Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Diseases; Lung Cancer; Tracheal Intubation Morbidity; Throat Injury; Bronchus; Injury
• Intervention / Treatment: Other: 3D reconstruction automatic matching system; Other: traditional method for selecting double lumen tube

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Wang, master; Phone Number: +8685420443; Email: 675202449@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D group; In 3D group, the investigator will intubate using DLT chosen by an automatic comparison software for 3D reconstruction based on CT data (3DRACS).	Other: 3D reconstruction automatic matching system; it is 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.
Placebo Comparator: control group; In control group, the size of DLT is based on patient's sex and weight and the height is used to guide the depth of DLT insertion.	Other: traditional method for selecting double lumen tube; In control group, the size of DLT is based on patient's sex and weight and the height is used to guide the depth of DLT insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of correct endobronchial intubation.	Conventional blindly endobronchial intubation is performed firstly and clinical verification was made by the same anesthesiologist, followed by the supervising anesthesiologist using a FOB to check DLT position and successful intubation was considered if the position was proper.	after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to successful intubation	after completion of induction, the vocal cords are exposed using visual laryngoscopy and Cormack-Lehane grading is performed. The stopwatch is timed as soon as the cuff of DLT crosses the vocal cords and it stops when (1) intubating anesthesiologist consider the DLT is correctly positioned, (2) after a maximum of three attempts have been made, (3) the intubating anesthesiologist think DLT placed correctly is impossible. Each attempt is defined as returning the bronchial lumen of the DLT to the trachea and then attempting to reinsert it. If the DLT is unsuccessfully placed, the intubation will be performed under FOB guidance by the supervising anesthesiologist. This intubation time of supervising anesthesiologist is also counted as part of the successful intubation time.	after intubation
Degree of pulmonary atrophy	it is a subjective score of 0-10 by the surgeon, ten mean very perfect, zero represent no pulmonary atrophy at all.	after surgery begin
Grading of airway injury	an anesthesiologist over 10 years of FOB experience will assess tracheal and vocal cord related injuries from DLT intubation. Before DLT is prepared to extubation, FOB will be inserted into the bronchial lumen and the tracheal injury will be observed through the FOB along with DLT extubated. All images from the FOB assessment are saved as a video and it will be viewed are by another blinded endoscopist to assess the injury of vocal cords. The severity of tracheal injury was defined as follows: mild (redness, oedema, one to three speckled haemorrhagic lesions), moderate (over 3 mild lesions or one diffuse haemorrhagic lesion) and severe (more than 2 diffuse haemorrhagic lesions). With regard to the vocal cords, the types of lesions are classified as follows: (1) oedema, swelling of the mucosa; (2) petechiae, small red spots on the mucosa; (3) haematoma, bleeding into the mucosa.	When extubation
Postoperative sore throat and hoarseness	sore throat is defined as persistent resting pain in the throat region, and throat pain scores were assessed by VAS score (0: no pain; 10: the most unbearable pain). Hoarseness is defined as a change in the quality of voice noted by the patient.	At 1 hour and 24 hours after extubation
Oxygenation during one-lung ventilation	it is defined as the area under the curve of the SpO2/FiO2 ratio during OLV. The SpO2 and FiO2 values are automatically collected by the monitor at 30 second intervals and any abnormal data due to equipment or human error will be replaced with the previous correct data.	Intraoperative（from beginning of one lung ventilation to end），an average of 2 hours
Account times of using FOB	it was defined that FOB was inserted into the tracheal tube and then withdrawn from the tracheal tube from induction to extubation.	During surgery (from induction to extubation), an average of 3 hour

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute
• Collaborators: Sichuan Province, Department of Science and Technology
• Investigators: Principal Investigator: Yihao Zhu, master, department of anesthesiology, sichuan cancer hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries
• Other Study ID Numbers: SCCHEC-02-2022-155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available on reasonable request. The raw data are available from the corresponding author with applicable reason after publishing findings to a peer-reviewed journal.
• IPD Sharing Time Frame: The raw data are available from the corresponding author with applicable reason after publishing findings to a peer-reviewed journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No