Patient Characteristics, Feasibility, and Outcomes of a Home Mechanical Ventilation Program in a Developing Country

October 5, 2016 updated by: Narongkorn Saiphoklang, MD, Thammasat University
This study aims to describe the patient characteristics, feasibility, and outcomes of an home mechanical ventilation (HMV) program at a university hospital in Thailand.

Study Overview

Detailed Description

Data will be collected on all patients who were discharged with HMV between October 2014 and August 2015 at Thammasat University Hospital. Data include sex, age, co-morbid diseases, clinical features, causes of HMV, mechanical ventilator and complimentary equipment characteristics, caregiver characteristics, ventilator and patient care costs, and morbidity and mortality outcomes of patients.

Study Type

Observational

Enrollment (Actual)

12

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

      • Pathumthani, Thailand, 12120
        • Department of Medicine, Faculty of Medicine, Thammasat 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

Non-Probability Sample

Study Population

All hospitalized patients requiring mechanical ventilation.

Description

Inclusion Criteria:

  • All hospitalized patients requiring mechanical ventilation aged 18 or more years.

Exclusion Criteria:

  • None.

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
Mortality rate of HMV patients
Time Frame: Up to 1 year
The number of deaths among HMV patients is recorded during follow-up period (up to 1 year)
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare home visit
Time Frame: Up to 1 year
Record the number of healthcare home visits (events)
Up to 1 year
Caregiver characteristics
Time Frame: Up to 1 year
Record the number of caregivers per patient, the number of well-trained caregivers
Up to 1 year
Family characteristics
Time Frame: Upto 1 year
Record types (relationships) and the number of family members, income to costs ratio
Upto 1 year
HMV complications due to tracheobronchitis
Time Frame: Up to 1 year
Record the number of tracheobronchitis (events) and the number of hospitalizations due to their effects
Up to 1 year
HMV complications due to ventilator-associated pneumonia
Time Frame: Up to 1 year
Record the number of ventilator-associated pneumonias (events) and the number of hospitalizations due to their effects
Up to 1 year
HMV complications due to the loose tracheostomy
Time Frame: Up to 1 year
Record the number of loose tracheostomies (events) and the number of hospitalizations due to their effects
Up to 1 year
HMV complications due to the granulation-tissue formation at tracheostomy
Time Frame: Up to 1 year
Record the number of granulation-tissue formations at tracheostomy (events) and the number of hospitalizations due to their effects
Up to 1 year
HMV complications due to pneumothorax
Time Frame: Up to 1 year
Record the number of pneumothoraces (events) and the number of hospitalizations due to their effects
Up to 1 year
HMV complications due to the ventilator malfunction
Time Frame: Up to 1 year
The number of ventilator malfunctions (events) and the number of hospitalizations due to their effects
Up to 1 year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Narongkorn Saiphoklang, MD, Faculty of Medicine, Thammasat 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

November 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 7, 2016

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • MTU-EC-IM-6-146/57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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