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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Other: Construction and evaluation of airway leakage risk model of patients with endotracheal tube

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Affiliated Hospital of Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the minimum cuff pressure	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	1min

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: HongLei wu, Affiliated Hospital of Nantong University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-K062-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No