Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube

There are two cases in which the cross-sectional area of the tracheal catheter balloon does not match the cross-sectional area of the patient's airway. If the area of the tracheal catheter balloon is smaller than the cross-sectional area of the patient's airway, the pressure in the balloon reaches 30 cmH2O, and the airway cannot be completely sealed; This will increase the risk of VAP. If the area of the tracheal catheter balloon is significantly larger than the cross-sectional area of the patient's airway, and the pressure in the balloon reaches 30 cmH2O, the airway cannot be effectively sealed; The formation of wrinkles around the airbag also increases the risk of VAP in patients. Therefore, the purpose of this study is to build a risk model of airway leakage of patients' endotracheal tubes, which provides an accurate and objective assessment tool for medical staff, so that medical staff can select the endotracheal tubes purposefully and with emphasis from the beginning of the patients' endotracheal tubes, and reduce the airway leakage or airway mucosal damage of the endotracheal tubes.

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Key information

Conditions

Mechanical Ventilation

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

About this study

Admission number, department, name, gender, height, and weight are obtained through the hospital's electronic medical record management system。 Tidal volume (set Tidal volume), airway peak pressure (real-time data on the ventilator screen), data collection is synchronized with the minimum cuff pressure measurement when the airway is closed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Invasive mechanical ventilation; Chest CT imaging examination within 1 year;

Exclusion criteria

Patients with pneumothorax Acute respiratory distress syndrome; Chronic Obstructive Pulmonary Disease; Multiple organ dysfunction.

Treatment and study plan

Construction and evaluation of airway leakage risk model of patients with endotracheal tube

Other

Conduct statistical analysis on general information, respiratory data, tracheal catheter data, and cross-sectional area of the patient's airway to clarify the current status of airway leakage and related influencing factors.
Based on multivariate logistic regression, a line chart prediction model for predicting the risk of airway leakage in patients with tracheal catheters is constructed. The clinical efficacy of the prediction model is evaluated by using the area under the ROC curve, the Calibration scatter plot, and the DCA decision line, respectively, to assess its discrimination, calibration, and clinical practicality.

Primary outcomes

Patient airway area

Time frame: Within 1 year

Firstly, confirm the front position of the tracheal catheter through chest X-ray, and then manually sketch the area of interest along the outer wall of the airway using Computed Tomography to calculate the area.

Secondary outcomes

Measure the minimum cuff pressure

Time frame: 1min

The specific method is as follows: the patient takes a 30 ° semi recumbent position, puts a Stethoscope on the throat of the patient's trachea, inflates air into the trachea tube cuff until the air leakage sound just disappears, at this time, the value displayed by the cuff pressure gauge is the minimum cuff pressure when the airway is closed

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Jun 27, 2023
Registry last updated: Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed