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

NCT05921656 | Completed

• 1 other identifier: 2021-K062-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Patient airway area

  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.

  Within 1 year

Secondary Outcomes (1)

• Measure the minimum cuff pressure

  1min

Interventions

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

1. 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. 2. 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.

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators selected mechanical ventilation patients admitted to the Extracardiac and Respiratory Care Units of Nantong University Affiliated Hospital from September 2021 to September 2022 who underwent cardiac, pulmonary, esophageal surgery, and other procedures as the research subjects.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

Related Publications (1)

• Selman Y, Arciniegas R, Sabra JM, Ferreira TD, Arnold DJ. Accuracy of the minimal leak test for endotracheal cuff pressure monitoring. Laryngoscope. 2020 Jul;130(7):1646-1650. doi: 10.1002/lary.28328. Epub 2019 Oct 8.

  PMID: 31593330 RESULT

MeSH Terms

Interventions

Facility Design and Construction

Intervention Hierarchy (Ancestors)

Architecture; Technology, Industry, and Agriculture; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• HongLei wu

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the investigators

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: June 27, 2023
• Study Start: September 30, 2021
• Primary Completion: September 30, 2022
• Study Completion: May 1, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CN (1)