Cancer of LungNCT06258954
Effect of 3D-printed Reconstruction System in Size of Left DLT
A study testing 3D reconstruction and traditional method for selecting double lumen tube in people with Cancer of Lung and Lung Isolation, run by Sichuan Cancer Hospital and Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of Lung, Lung Isolation
- What is being tested?
- 3D reconstruction 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 Apr 2024to 30 Jul 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 Selecting the Size of Left Double-lumen Tube
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.
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. The investigators 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 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
- Cancer of Lung, Lung Isolation
- Being tested
- 3D reconstruction, traditional method for selecting double lumen tube
- Keywords
- Lung isolation, double-lumen tube, Three-dimensional reconstruction
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D reconstructionOther
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.
traditional method for selecting double lumen tubeOther
In control group, the size of DLT is based on patient's sex and height.
| Study group | Role | What they receive |
|---|---|---|
| 3D group | Experimental | Using automatic comparison software for 3D reconstruction to determine the size of DLT. Receives: Other: 3D reconstruction |
| control group | Placebo comparator | The size of DLT is based on patient's sex and height. 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.
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.
Measured: After intubation，an average of 2 hours
Secondary outcomes (8)
The time of completing the left DLT's position
There are two different situations that we need to describe. First, it starts from the cuff of left DLT crosses the vocal cords, and stops when the left DLT position succeeds without FOB(attempts≤3）. A stopwatch is used for this purpose, where it is ON when the cuff of left DLT crosses the vocal cords and stops when intubating anesthesiologist considers the left DLT is correctly positioned. Second, it starts from the cuff of left DLT crosses the vocal cords and stops when positioning successfully with FOB after three attempts all fail. Each attempt is defined as returning the bronchial lumen of the left DLT to the trachea and then attempting to reinsert it.
Measured: After intubation，an average of 2 hours
The number of the patients who need to change the size of the left DLT
If the position of the left DLT under the FOB guidance doesn't match and the intubation fails because of the improper size of the left DLT, we need to change another left DLT.
Measured: After intubation，an average of 2 hours
Appropriate standard for the left DLT
Objective criteria is injecting air into the cuff. When the pressure inside the left DLT is 25 mmHg, it will be stopped and connected to the anesthesia machine. And the air leakage phenomenon is adjusted when the peak pressure is lower than 30 cm H2O. Oversized left DLT is defined that good pulmonary isolation could be achieved by injecting <1 ml of air into the bronchial cuff and <2 ml of air into the main tracheal cuff, while more than 3 or 6 ml of air into the two cuff is defined undersized left DLT.
Measured: After intubation，an average of 2 hours
Lung collapse
Ten and 20 min after pleurotomy, the degree of pulmonary atrophy is assessed by a chest surgeon unaware of the grouping with an eleven-point Likert scale with 0 marked as no pulmonary atrophy at all and 10 as most perfect lung collapse.
Measured: At 10 and 20 minute after pleurotomy
Grading of the airway injury
it will be done by a trained anesthesiologist with over 10 years of FOB experience, The severity of the tracheal injury is defined as mild (redness, edema, one to three speckled hemorrhagic lesions), moderate (over 3 mild lesions or one diffuse hemorrhagic lesion), and severe (more than 2 diffuse hemorrhagic lesions) The type of lesions in vocal cords is classified into edema with inflamed mucosa, petechiae (small red spots on the mucosa), and hematoma (bleeding into the mucosa).
Measured: After extubation，an average of 1 hours
Postoperative sore throat and hoarseness
they are defined as persistent resting pain in the throat region, where throat pain scores are assessed using VAS score i.e., 0 for no pain, and 10 for unbearable pain, while hoarseness is defined as a change in the quality of voice observed by the patient.
Measured: 1, 2 days after surgery
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 is replaced with the previous correct data.
Measured: At the end of surgery.
Times of using FOB
The times of using FOB guiding to place the left DLT correctly after three attempts all fail.
Measured: At the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of LungStudies 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
- 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
- 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
- NCT06258954
- Sponsor's protocol ID
- scchec-20240128
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38754878
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3D-printed Reconstruction Automated Matching System in Selecting the Size of Left Double-lumen Tube
- ClinicalTrials.gov ID
- NCT06258954
- Acronym / sponsor ID
- scchec-20240128
- Conditions
- Cancer of Lung, Lung Isolation
- Keywords
- Lung isolation, double-lumen tube, Three-dimensional reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 14 Feb 2024 (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.
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.
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. The investigators 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 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
| Arm | Type | Receives |
|---|---|---|
| 3D group | Experimental | Other: 3D reconstructionUsing automatic comparison software for 3D reconstruction to determine the size of DLT. |
| control group | Placebo comparator | Other: traditional method for selecting double lumen tubeThe size of DLT is based on patient's sex and height. |
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 reconstruction3D 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. | Other | 3D group |
| traditional method for selecting double lumen tubeIn control group, the size of DLT is based on patient's sex and height. | Other | control group |
Primary outcome
the success rates of placement of left DLT without FOB
Time frame: After intubation，an average of 2 hours
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.
8 secondary outcomes
The time of completing the left DLT's position
Time frame: After intubation，an average of 2 hours
The number of the patients who need to change the size of the left DLT
Time frame: After intubation，an average of 2 hours
Appropriate standard for the left DLT
Time frame: After intubation，an average of 2 hours
Lung collapse
Time frame: At 10 and 20 minute after pleurotomy
Grading of the airway injury
Time frame: After extubation，an average of 1 hours
Postoperative sore throat and hoarseness
Time frame: 1, 2 days after surgery
Oxygenation during one-lung ventilation
Time frame: At the end of surgery.
Times of using FOB
Time frame: At the end of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 38754878Li 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.
- Individual participant dataSharing planned: No. 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 and traditional method for selecting double lumen tube in people with Cancer of Lung and Lung Isolation, 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 14 Feb 2024. 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?
the success rates of placement of left DLT without FOB (time frame: After intubation，an average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06258954, which also lists 1 linked publication.
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 14 Feb 2024.