Airway ManagementNCT06709053
A Clinical Study on Predicting the Depth of Double-Lumen Tube Insertion Based on Height and Sitting Height
A study testing standing hight-based, sitting height-based and CT-based in people with Airway Management, run by Tongji Hospital at 1 site in China.
Trial summary
This study employed a combined observational derivation and randomized validation approach to establish and evaluate predictive models for the depth of DLT insertion (Figure 1). Initially, a total of 98 patients scheduled for thoracic surgery involving one-lung ventilation were screened for participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- standing hight-based, sitting height-based and CT-based
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 418 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2024to 26 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in research;
- Age ≥18 years and ≤80 years;
- Patients receiving general anesthesia and DLT tracheal intubation.
Who cannot join
- Patients with scoliosis or deformity;
- Patients who are unable to stand upright or sit;
- Patients with maxillary malformations or misaligned incisors;
- The researchers judged that it was not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Clinical Study Comparing the Prediction of Double-Lumen Tube Insertion Depth Based on Height and Sitting Height
This study employed a combined observational derivation and randomized validation approach to establish and evaluate predictive models for the depth of DLT insertion (Figure 1). Initially, a total of 98 patients scheduled for thoracic surgery involving one-lung ventilation were screened for participation. Sixteen patients were subsequently excluded because DLT was not performed, resulting in 82 participants included in the final analysis. This phase led to the development of three predictive formulas for DLT insertion depth: based on standing height (Depth = 1.083 + 0.166 × standing height), sitting height (Depth = 0.32 × SH), and an integrated model combining body height and sternum-carina distance (Ds-c: Depth = 1.543 + 0.155 × standing height + 0.202 × Ds-c).
The subsequent phase involved a triple-arm randomized controlled trial (RCT) with 336 patients to compare these predictive models. Sample size was calculated to detect a 0.3 cm error reduction with 90% power (α=0.05), requiring 102/group; 112/group were enrolled accounting for 10% attrition. The random allocation ratio was 1:1:1, ensuring equal distribution among three groups: standing height (height-based formula), sitting height (sitting height-based formula), and CT (CT-guided formula). Prespecified primary endpoints were: (1) Absolute error (continuous; mean difference in cm), (2) Clinical accuracy (binary; proportion with optimal positioning). Secondary outcomes included tube mispositioning rates.
Read the detailed description
CT Measurement Methodology Thoracic CT scans were performed according to the hospital's standard diagnostic protocol and analyzed using OsiriX imaging software. Various anatomical measurements obtained from CT scans were used to predict intubation depth, including the distances from the vocal cords to the carina (Dv-c), from the cricoid to the carina (Dc-c), and from the thoracic inlet to the carina (Ds-c). Although the Dv-c measurement demonstrated the highest predictive accuracy at 90%, its clinical applicability was limited in our control group for two key reasons23. First, the standard lung CT protocol did not include imaging of the vocal cords, leading to insufficient data for this measurement in most patients. Second, marking the catheter at the glottis level prior to intubation was essential for observational purposes but did not interfere with the anesthesia induction process. Consequently, Ds-c was ultimately selected as the primary measurement for this study due to its superior predictive accuracy.
DLT Positioning Criteria The optimal positioning of the DLT was defined as having the bronchial cuff located in the main bronchus, with its edge positioned within 0.5 cm below the carina or at the carina level to ensure unobstruction of the opposite main bronchus. Additional criteria specified that the catheter tip should not obstruct the lobar bronchus opening, and the side hole should be situated above the carina, directly facing the main bronchus opening on the contralateral side. Surgeons confirmed satisfactory lung collapse on the operative side. Fiberoptic bronchoscopy was utilized to assess the optimal placement of the DLT, with evaluations conducted in the supine position after induction and again in the lateral position prior to the procedure. In the observational cohort, intubation was performed first, followed by verification. In the validation cohort, an independent physician calculated the insertion depth based on the predictive formulas. The anesthesiologist, unaware of group assignments, inserted the DLT according to the calculated depth, which was subsequently assessed by another independent physician using fiberoptic bronchoscopy. The DLT position was recorded as accurate if it fell within the optimal range; otherwise, it was deemed inaccurate.
Establishment of Prediction Formulas In the derivation cohort, standing height, sitting height, and Ds-c were documented for all participants prior to surgery. Following the induction of general anesthesia, patients were positioned for surgery, and one-lung ventilation commenced. The investigator recorded the catheter type and depth after the surgeon approved lung collapse on the operated side, and the anesthesiologist confirmed the catheter's optimal position using fiberoptic bronchoscopy. Regression analysis was employed to derive the prediction formulas based on height and CT measurements Validation Phase Protocol The RCT phase randomized 336 eligible patients equally into three groups using a computer-generated allocation: standing height (height-based formula), sitting height (sitting height-based formula), and CT (CT-guided formula). Preoperative standing height/sitting height measurements, as well as CT analysis, were completed before randomization. Anesthesiologists accessed group assignments through sealed opaque envelopes after patient positioning. All intubations were performed by senior airway specialists using manufacturer-recommended DLT sizes, with initial placement at the formula-predicted depth. After anesthesia induction, patients were positioned laterally to ensure alignment of the head and neck with the spine. An additional observer, blinded to group assignments, used fiberoptic bronchoscopy through the side hole of the bronchial tube to assess the location of the bronchial cuff. The target was to achieve the 'predicted depth.' Data were considered accurate if the depth fell within the 'optimal position' range. If the 'predicted depth' was not attained but a safe critical point was reached, adjustments to the catheter position were halted, and the data were recorded as inaccurate. Depths were classified as shallow if below the 'optimal position' and deep if exceeding it. All intubating anesthesiologists were board-certified specialists with >200 documented DLT placements and current certification in advanced airway management.
Blinding Procedures Participants, outcome assessors, data analysts, and data collectors were fully blinded to group allocation, while intubating clinicians were masked to group assignment and prediction formulas. Independent outcomes assessment was ensured through a three-level blinding system: (1) intubating clinicians received only numerical insertion depths from an independent coordinator without access to prediction methods or group information; (2) fiberoptic bronchoscopy verification used video recordings anonymized by removing group and patient identifiers; and (3) data collection was performed by research nurses unaware of allocations while data analysts processed datasets stripped of randomization codes. Identical interventions were maintained across all groups through standardized DLT models, uniform intubation equipment, and consistent procedural protocols.
Harm Monitoring Procedure-related adverse events specifically attributable to DLT placement (including mucosal injury and hypoxemia defined as SpO₂ <90% persisting >30 seconds) were assessed during standardized bronchoscopic verification. No study-related complications occurred.
Statistical Analysis No interim analyses were planned or performed given low procedural risk and fixed enrollment target. Stopping rules would trigger if >10% participants experienced protocol-defined serious adverse events (e.g., bronchial rupture). All statistical analyses were conducted using R (version 4.1.1; R Foundation for Statistical Computing, Vienna, Austria). Statistical significance was defined as a two-sided P value <0.05.
Descriptive statistics were used to summarize baseline characteristics. Continuous variables were assessed for normality using skewness, kurtosis, and visual inspection of histograms. Normally distributed variables were reported as means with standard errors (SE) and compared using independent samples t-tests. Non-normally distributed data were summarized as medians with interquartile ranges (IQR) and compared using the Mann-Whitney U test. Categorical variables were presented as counts and percentages and analyzed using Pearson's χ² test.
To evaluate the association between anthropometric measurements (standing height, sitting height, sternum-carina distance) and actual double-lumen tube (DLT) depth, Spearman correlation coefficients were calculated.
The primary analysis compared the predictive accuracy of three models (standing height-based, sitting height-based, and CT-guided) using a one-way analysis of variance (ANOVA). When ANOVA indicated statistical significance and homogeneity of variances (tested using Levene's test), Tukey's honestly significant difference (HSD) post hoc test was applied to identify pairwise differences between groups.
Prediction error (absolute difference between predicted and actual DLT depth) was treated as a continuous outcome and analyzed as described above. Clinical accuracy (defined as correct initial DLT positioning without repositioning) was analyzed as a binary outcome. Between-group comparisons were made using χ² tests, and subgroup analyses were conducted stratified by sex and torso proportions (sitting height <85 cm vs. ≥85 cm).
Missing data were minimal and handled using complete-case analysis. No imputation was performed. All analyses were conducted according to the intention-to-treat principle.
- Conditions
- Airway Management
- Being tested
- standing hight-based, sitting height-based, CT-based
- Keywords
- Airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standing hight-basedDiagnostic test
The model equation for predicting double-lumen tube insertion depth using standing hight -based: Depth = 1.083 + 0.166×standing hight (cm)
sitting height-basedDiagnostic test
The model equation for predicting double-lumen tube insertion depth using sitting height ( depth = 0.32 × sitting height)
CT-basedDiagnostic test
The model equation for predicting double-lumen tube insertion depth using CT depth = 1.543 + 0.155*standing hight,cm + 0.202*Ds-c,cm
| Study group | Role | What they receive |
|---|---|---|
| Standing-based | Sham comparator | The model equation for predicting double-lumen tube insertion depth using standing height -based: Depth = 1.083 + 0.166×BH (cm) Receives: Diagnostic Test: standing hight-based |
| sitting hight-based | Experimental | The model equation for predicting double-lumen tube insertion depth using sitting height (depth = 0.32 × sitting height) Receives: Diagnostic Test: sitting height-based |
| CT-based | Experimental | The model equation for predicting double-lumen tube insertion depth using CT (depth = 1.543 + 0.155*standing height,cm + 0.202*Ds-c,cm). Receives: Diagnostic Test: CT-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of Double-Lumen Tube Insertion
The distance from the incisor to the protuberance was measured and recorded by fiberoptic bronchoscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start25 Nov 2024
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Zhang, Tongji Hospital
- Investigators
- Qin Zhang, phd, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709053
- Sponsor's protocol ID
- TJ-IRB202411040
- Status last verified
- Aug 2025
- First submitted
- 25 Nov 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing the Prediction of Double-Lumen Tube Insertion Depth Based on Height and Sitting Height
- ClinicalTrials.gov ID
- NCT06709053
- Acronym / sponsor ID
- TJ-IRB202411040
- Conditions
- Airway Management
- Keywords
- Airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 29 Nov 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.
This study employed a combined observational derivation and randomized validation approach to establish and evaluate predictive models for the depth of DLT insertion (Figure 1). Initially, a total of 98 patients scheduled for thoracic surgery involving one-lung ventilation were screened for participation. Sixteen patients were subsequently excluded because DLT was not performed, resulting in 82 participants included in the final analysis. This phase led to the development of three predictive formulas for DLT insertion depth: based on standing height (Depth = 1.083 + 0.166 × standing height), sitting height (Depth = 0.32 × SH), and an integrated model combining body height and sternum-carina distance (Ds-c: Depth = 1.543 + 0.155 × standing height + 0.202 × Ds-c).
The subsequent phase involved a triple-arm randomized controlled trial (RCT) with 336 patients to compare these predictive models. Sample size was calculated to detect a 0.3 cm error reduction with 90% power (α=0.05), requiring 102/group; 112/group were enrolled accounting for 10% attrition. The random allocation ratio was 1:1:1, ensuring equal distribution among three groups: standing height (height-based formula), sitting height (sitting height-based formula), and CT (CT-guided formula). Prespecified primary endpoints were: (1) Absolute error (continuous; mean difference in cm), (2) Clinical accuracy (binary; proportion with optimal positioning). Secondary outcomes included tube mispositioning rates.
Detailed description
CT Measurement Methodology Thoracic CT scans were performed according to the hospital's standard diagnostic protocol and analyzed using OsiriX imaging software. Various anatomical measurements obtained from CT scans were used to predict intubation depth, including the distances from the vocal cords to the carina (Dv-c), from the cricoid to the carina (Dc-c), and from the thoracic inlet to the carina (Ds-c). Although the Dv-c measurement demonstrated the highest predictive accuracy at 90%, its clinical applicability was limited in our control group for two key reasons23. First, the standard lung CT protocol did not include imaging of the vocal cords, leading to insufficient data for this measurement in most patients. Second, marking the catheter at the glottis level prior to intubation was essential for observational purposes but did not interfere with the anesthesia induction process. Consequently, Ds-c was ultimately selected as the primary measurement for this study due to its superior predictive accuracy.
DLT Positioning Criteria The optimal positioning of the DLT was defined as having the bronchial cuff located in the main bronchus, with its edge positioned within 0.5 cm below the carina or at the carina level to ensure unobstruction of the opposite main bronchus. Additional criteria specified that the catheter tip should not obstruct the lobar bronchus opening, and the side hole should be situated above the carina, directly facing the main bronchus opening on the contralateral side. Surgeons confirmed satisfactory lung collapse on the operative side. Fiberoptic bronchoscopy was utilized to assess the optimal placement of the DLT, with evaluations conducted in the supine position after induction and again in the lateral position prior to the procedure. In the observational cohort, intubation was performed first, followed by verification. In the validation cohort, an independent physician calculated the insertion depth based on the predictive formulas. The anesthesiologist, unaware of group assignments, inserted the DLT according to the calculated depth, which was subsequently assessed by another independent physician using fiberoptic bronchoscopy. The DLT position was recorded as accurate if it fell within the optimal range; otherwise, it was deemed inaccurate.
Establishment of Prediction Formulas In the derivation cohort, standing height, sitting height, and Ds-c were documented for all participants prior to surgery. Following the induction of general anesthesia, patients were positioned for surgery, and one-lung ventilation commenced. The investigator recorded the catheter type and depth after the surgeon approved lung collapse on the operated side, and the anesthesiologist confirmed the catheter's optimal position using fiberoptic bronchoscopy. Regression analysis was employed to derive the prediction formulas based on height and CT measurements Validation Phase Protocol The RCT phase randomized 336 eligible patients equally into three groups using a computer-generated allocation: standing height (height-based formula), sitting height (sitting height-based formula), and CT (CT-guided formula). Preoperative standing height/sitting height measurements, as well as CT analysis, were completed before randomization. Anesthesiologists accessed group assignments through sealed opaque envelopes after patient positioning. All intubations were performed by senior airway specialists using manufacturer-recommended DLT sizes, with initial placement at the formula-predicted depth. After anesthesia induction, patients were positioned laterally to ensure alignment of the head and neck with the spine. An additional observer, blinded to group assignments, used fiberoptic bronchoscopy through the side hole of the bronchial tube to assess the location of the bronchial cuff. The target was to achieve the 'predicted depth.' Data were considered accurate if the depth fell within the 'optimal position' range. If the 'predicted depth' was not attained but a safe critical point was reached, adjustments to the catheter position were halted, and the data were recorded as inaccurate. Depths were classified as shallow if below the 'optimal position' and deep if exceeding it. All intubating anesthesiologists were board-certified specialists with >200 documented DLT placements and current certification in advanced airway management.
Blinding Procedures Participants, outcome assessors, data analysts, and data collectors were fully blinded to group allocation, while intubating clinicians were masked to group assignment and prediction formulas. Independent outcomes assessment was ensured through a three-level blinding system: (1) intubating clinicians received only numerical insertion depths from an independent coordinator without access to prediction methods or group information; (2) fiberoptic bronchoscopy verification used video recordings anonymized by removing group and patient identifiers; and (3) data collection was performed by research nurses unaware of allocations while data analysts processed datasets stripped of randomization codes. Identical interventions were maintained across all groups through standardized DLT models, uniform intubation equipment, and consistent procedural protocols.
Harm Monitoring Procedure-related adverse events specifically attributable to DLT placement (including mucosal injury and hypoxemia defined as SpO₂ <90% persisting >30 seconds) were assessed during standardized bronchoscopic verification. No study-related complications occurred.
Statistical Analysis No interim analyses were planned or performed given low procedural risk and fixed enrollment target. Stopping rules would trigger if >10% participants experienced protocol-defined serious adverse events (e.g., bronchial rupture). All statistical analyses were conducted using R (version 4.1.1; R Foundation for Statistical Computing, Vienna, Austria). Statistical significance was defined as a two-sided P value <0.05.
Descriptive statistics were used to summarize baseline characteristics. Continuous variables were assessed for normality using skewness, kurtosis, and visual inspection of histograms. Normally distributed variables were reported as means with standard errors (SE) and compared using independent samples t-tests. Non-normally distributed data were summarized as medians with interquartile ranges (IQR) and compared using the Mann-Whitney U test. Categorical variables were presented as counts and percentages and analyzed using Pearson's χ² test.
To evaluate the association between anthropometric measurements (standing height, sitting height, sternum-carina distance) and actual double-lumen tube (DLT) depth, Spearman correlation coefficients were calculated.
The primary analysis compared the predictive accuracy of three models (standing height-based, sitting height-based, and CT-guided) using a one-way analysis of variance (ANOVA). When ANOVA indicated statistical significance and homogeneity of variances (tested using Levene's test), Tukey's honestly significant difference (HSD) post hoc test was applied to identify pairwise differences between groups.
Prediction error (absolute difference between predicted and actual DLT depth) was treated as a continuous outcome and analyzed as described above. Clinical accuracy (defined as correct initial DLT positioning without repositioning) was analyzed as a binary outcome. Between-group comparisons were made using χ² tests, and subgroup analyses were conducted stratified by sex and torso proportions (sitting height <85 cm vs. ≥85 cm).
Missing data were minimal and handled using complete-case analysis. No imputation was performed. All analyses were conducted according to the intention-to-treat principle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standing-based | Sham comparator | Diagnostic Test: standing hight-basedThe model equation for predicting double-lumen tube insertion depth using standing height -based: Depth = 1.083 + 0.166×BH (cm) |
| sitting hight-based | Experimental | Diagnostic Test: sitting height-basedThe model equation for predicting double-lumen tube insertion depth using sitting height (depth = 0.32 × sitting height) |
| CT-based | Experimental | Diagnostic Test: CT-basedThe model equation for predicting double-lumen tube insertion depth using CT (depth = 1.543 + 0.155*standing height,cm + 0.202*Ds-c,cm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntary participation in research;
- Age ≥18 years and ≤80 years;
- Patients receiving general anesthesia and DLT tracheal intubation.
Key exclusion criteria (4 listed)
- Patients with scoliosis or deformity;
- Patients who are unable to stand upright or sit;
- Patients with maxillary malformations or misaligned incisors;
- The researchers judged that it was not suitable to participate in this study.
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 |
|---|---|---|
| standing hight-basedThe model equation for predicting double-lumen tube insertion depth using standing hight -based: Depth = 1.083 + 0.166×standing hight (cm) | Diagnostic test | Standing-based |
| sitting height-basedThe model equation for predicting double-lumen tube insertion depth using sitting height ( depth = 0.32 × sitting height) | Diagnostic test | sitting hight-based |
| CT-basedThe model equation for predicting double-lumen tube insertion depth using CT depth = 1.543 + 0.155*standing hight,cm + 0.202*Ds-c,cm | Diagnostic test | CT-based |
Primary outcome
Depth of Double-Lumen Tube Insertion
Time frame: 1 day
The distance from the incisor to the protuberance was measured and recorded by fiberoptic bronchoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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.
Qin Zhang, phd principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standing hight-based, sitting height-based and CT-based in people with Airway Management, run by Tongji Hospital at 1 site in China.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of Double-Lumen Tube Insertion (time frame: 1 day). 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 11 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.