MedTrace Logo

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

NCT06709053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2025-08-11

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

standing hight-based

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

DIAGNOSTIC_TEST

sitting height-based

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

DIAGNOSTIC_TEST

CT-based

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

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Qin Zhang, phd · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2025-02-26
Completion
2025-02-26

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06709053 on ClinicalTrials.gov