Lung CancerNCT05899270
3D-printed Reconstruction Automated Matching System Predicts Size of Double-lumen Tube: a Prospective Double-blinded Randomized Controlled Trial
A study testing 3D reconstruction automatic matching system and traditional method for selecting double lumen tube in people with Lung Cancer and Lung Diseases, run by Sichuan Cancer Hospital and Research Institute.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Lung Diseases, Tracheal Intubation Morbidity
- What is being tested?
- 3D reconstruction automatic matching system and traditional method for selecting double lumen tube
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Lung Diseases, Tracheal Intubation Morbidity, Throat Injury, Bronchus; Injury
- Being tested
- 3D reconstruction automatic matching system, traditional method for selecting double lumen tube
- Medical subject headings
- Lung Neoplasms, Lung Diseases, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D reconstruction automatic matching systemOther
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.
traditional method for selecting double lumen tubeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: traditional method for selecting double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after intubation
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During surgery (from induction to extubation), an average of 3 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Technology Department of Sichuan Province
- Responsible party
- Principal investigator, Yihao Zhu, Sichuan Cancer Hospital and Research Institute
- Investigators
- Yihao Zhu, master, Principal investigator, department of anesthesiology, sichuan cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899270
- Sponsor's protocol ID
- SCCHEC-02-2022-155
- Status last verified
- Jun 2023
- First submitted
- 17 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3D-printed Reconstruction Automated Matching System in Size Selection of Double-lumen Tube：a Prospective Double-blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05899270
- Acronym / sponsor ID
- SCCHEC-02-2022-155
- Conditions
- Lung Cancer, Lung Diseases, Tracheal Intubation Morbidity, Throat Injury, Bronchus; Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- Science and Technology Department of Sichuan Province
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3D group | Experimental | Other: 3D reconstruction automatic matching systemIn 3D group, the investigator will intubate using DLT chosen by an automatic comparison software for 3D reconstruction based on CT data (3DRACS). |
| control group | Placebo comparator | Other: traditional method for selecting double lumen tubeIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- The participant experiences any of the following：
- Spinal malformation,
- Expected difficult airway
- Tracheal stenosis
- Tracheal tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D reconstruction automatic matching systemit 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. | Other | 3D group |
| traditional method for selecting double lumen tubeIn 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 | control group |
Primary outcome
Incidence of correct endobronchial intubation.
Time frame: after 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.
6 secondary outcomes
Time to successful intubation
Time frame: after intubation
Degree of pulmonary atrophy
Time frame: after surgery begin
Grading of airway injury
Time frame: When extubation
Postoperative sore throat and hoarseness
Time frame: At 1 hour and 24 hours after extubation
Oxygenation during one-lung ventilation
Time frame: Intraoperative（from beginning of one lung ventilation to end），an average of 2 hours
Account times of using FOB
Time frame: During surgery (from induction to extubation), an average of 3 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yihao Zhu, master principal investigator
department of anesthesiology, sichuan cancer hospital
Questions about this trial
What is this clinical trial studying?
A study testing 3D reconstruction automatic matching system and traditional method for selecting double lumen tube in people with Lung Cancer and Lung Diseases, run by Sichuan Cancer Hospital and Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Wang, master (+8685420443, 675202449@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of correct endobronchial intubation. (time frame: after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.