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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in China

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.

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 groups in NCT06709053
Study groupRoleWhat they receive
Standing-basedSham comparatorThe 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-basedExperimentalThe model equation for predicting double-lumen tube insertion depth using sitting height (depth = 0.32 × sitting height)
Receives: Diagnostic Test: sitting height-based
CT-basedExperimentalThe 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.

  1. 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.

  1. First posted29 Nov 2024
  2. Study start25 Nov 2024
  3. Primary completion26 Feb 2025
  4. Study completion26 Feb 2025

Resources

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)
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

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.

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