The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial

October 25, 2022 updated by: Ke-Yun, Chao, Fu Jen Catholic University

The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial: Before and After Tracheostomy

The aim of this study is to investigate the use of Edi in patients under the endotracheal tube and tracheostomy, and analysis of cardiopulmonary parameters in adult patients.

Study Overview

Status

Terminated

Conditions

Detailed Description

Tracheostomy is a utilitarian surgical procedure of access; therefore, it should be discussed in light of the problem it addresses: access to the tracheobronchial tree. The trachea is a conduit between the upper airway and the lungs that delivers moist warm air and expels carbon dioxide and sputum. Failure or blockage at any point along that conduit can be most readily corrected with the provision of access for mechanical ventilators and suction equipment. In the case of upper airway obstruction, tracheostomy provides a path of low resistance for air exchange.

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Fu Jen Catholic University Hospital, Fu Jen Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient in a single intensive care unit, under planning tracheostomy will enroll to this study.

Description

Inclusion Criteria:

  • Patents under planning tracheostomy will enroll to this study.

Exclusion Criteria:

  • Pregnant women, age under 18 and unable to insert nasogastric tube

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The electrical activity of the diaphragm (Edi)
Time Frame: one year
Edi is the primary requirement for NAVA to function and the main source for ventilator trigger. This study will find the difference of data of Edi after surgery
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary function parameters
Time Frame: one year
heart rate (HR)
one year
Cardiopulmonary function parameters
Time Frame: one year
blood pressure (BP)
one year
Cardiopulmonary function parameters
Time Frame: one year
stroke volume (SV)
one year
Cardiopulmonary function parameters
Time Frame: one year
cardiac output (CO)
one year
Cardiopulmonary function parameters
Time Frame: one year
total peripheral resistance (TPR)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

February 6, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PL-2020100X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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