A Clinical Study on Predicting the Depth of Double-Lumen Tube Insertion Based on Height and Sitting Height

NCT06709053 | Completed

• 1 other identifier: TJ-IRB202411040
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Airway Management

Keywords

Airway management

Outcome Measures

Primary Outcomes (1)

• Depth of Double-Lumen Tube Insertion

  The distance from the incisor to the protuberance was measured and recorded by fiberoptic bronchoscopy

  1 day

Study Arms (3)

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)

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)

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).

Diagnostic Test: CT-based

Interventions

standing hight-based DIAGNOSTIC_TEST

The model equation for predicting double-lumen tube insertion depth using standing hight -based: Depth = 1.083 + 0.166×standing hight (cm)

Standing-based

sitting height-based DIAGNOSTIC_TEST

The model equation for predicting double-lumen tube insertion depth using sitting height ( depth = 0.32 × sitting height)

sitting hight-based

CT-based DIAGNOSTIC_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

CT-based

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in research;
• Age ≥18 years and ≤80 years;
• Patients receiving general anesthesia and DLT tracheal intubation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

• Qin Zhang, phd

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients and the personnel measuring the depth did not know the grouping
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: November 25, 2024
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)