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

NCT05899270 | Unknown

• 1 other identifier: SCCHEC-02-2022-155
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer; Lung Diseases; Tracheal Intubation Morbidity; Throat Injury; Bronchus; Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to successful intubation

  after intubation

• Degree of pulmonary atrophy

  after surgery begin

• Grading of airway injury

  When extubation

• Postoperative sore throat and hoarseness

  At 1 hour and 24 hours after extubation

• Oxygenation during one-lung ventilation

  Intraoperative（from beginning of one lung ventilation to end），an average of 2 hours

Study Arms (2)

3D group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

3D reconstruction automatic matching system OTHER

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.

3D group

traditional method for selecting double lumen tube OTHER

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.

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
• Science and Technology Department of Sichuan Province: collaborator

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases; Wounds and Injuries

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; 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
• Masking Details: Two investigators performing intubation of DLT will be blinded to the intervention. All participates and researchers responsible for surgery, bronchoscopy assessment, follow-up, data management and analysis will also be blinded to the grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 12, 2023
• Study Start: November 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: March 30, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The raw data are available from the corresponding author with applicable reason after publishing findings to a peer-reviewed journal.