NCT06709053

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

Completed NA Last updated 11 August 2025

What this trial tests

NA trial testing standing hight-based in Airway Management in 418 participants. Completed in 26 February 2025.

Timeline

25 November 2024

Primary endpoint
26 February 2025

26 February 2025

Quick facts

Lead sponsor	Tongji Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	418
Start date	25 November 2024
Primary completion	26 February 2025
Estimated completion	26 February 2025
Sites	1 location across China

Drugs / interventions tested

• standing hight-based
• sitting height-based
• CT-based

Conditions studied

• Airway Management — all drugs for Airway Management →

Sponsor

Tongji Hospital

Who can join

18 and older, any sex, with Airway Management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.