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

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Completed
CT.gov ID
NCT05921656
Collaborator
(none)
220
1
19
11.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
220 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube
Actual Study Start Date :
Sep 30, 2021
Actual Primary Completion Date :
Sep 30, 2022
Actual Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Patient airway area [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 Outcome Measures

  1. Measure the minimum cuff pressure [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Nantong University Nantong Jiangsu China 226001

Sponsors and Collaborators

  • Affiliated Hospital of Nantong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Honglei Wu, the investigators, Affiliated Hospital of Nantong University
ClinicalTrials.gov Identifier:
NCT05921656
Other Study ID Numbers:
  • 2021-K062-01
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 27, 2023