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

NCT06258954 | Not Yet Recruiting DMC

• 1 other identifier: scchec-20240128
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer of Lung; Lung Isolation

Keywords

Lung isolation; double-lumen tube; Three-dimensional reconstruction

Outcome Measures

Primary Outcomes (1)

• the success rates of placement of left DLT without FOB

  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，an average of 2 hours

Secondary Outcomes (8)

• The time of completing the left DLT's position

  After intubation，an average of 2 hours

• The number of the patients who need to change the size of the left DLT

  After intubation，an average of 2 hours

• Appropriate standard for the left DLT

  After intubation，an average of 2 hours

• Lung collapse

  At 10 and 20 minute after pleurotomy

• Grading of the airway injury

  After extubation，an average of 1 hours

Study Arms (2)

3D group

EXPERIMENTAL

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

Other: 3D reconstruction

control group

PLACEBO COMPARATOR

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

Other: traditional method for selecting double lumen tube

Interventions

3D reconstruction 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.

3D group

traditional method for selecting double lumen tube OTHER

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

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years.
• American Society of Anesthesiologists Physical Status (ASA-PS) I-III.
• Planned to receive lung resection surgery during lung isolation techniques by using DLT.
• Signed informed written consent.

You may not qualify if:

• The participant experiences any of the following：
• Spinal malformation,
• Expected difficult airway
• Tracheal stenosis
• Tracheal tumor
• Bronchial tumor
• Distorted airway anatomy
• Tumors of the mouth or neck

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Related Publications (1)

• Li L, Zhu Y, Yin F, Yu H, Wang H, Xu Y, Fei F, Liu W, Duan B, Wang F, Jia Y, Zhang H. Effect of a 3D-printed reconstruction automated matching system for selecting the size of a left double-lumen tube: a study protocol for a prospective randomised controlled trial. BMJ Open. 2024 May 15;14(5):e085503. doi: 10.1136/bmjopen-2024-085503.

  PMID: 38754878 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yihao Zhu, master

  department of anesthesiology, sichuan cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wang, master

CONTACT

+8685420443; 675202449@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 14, 2024
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share