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

Sponsor
Thammasat University (Other)
Overall Status
Completed
CT.gov ID
NCT02927613
Collaborator
(none)
12
1
12
1

Study Details

Study Description

Brief Summary

This study aims to describe the patient characteristics, feasibility, and outcomes of an home mechanical ventilation (HMV) program at a university hospital in Thailand.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Patient Characteristics, Feasibility, and Outcomes of a Home Mechanical Ventilation Program in a Developing Country
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Nov 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Mortality rate of HMV patients [Up to 1 year]

      The number of deaths among HMV patients is recorded during follow-up period (up to 1 year)

    Secondary Outcome Measures

    1. Healthcare home visit [Up to 1 year]

      Record the number of healthcare home visits (events)

    2. Caregiver characteristics [Up to 1 year]

      Record the number of caregivers per patient, the number of well-trained caregivers

    3. Family characteristics [Upto 1 year]

      Record types (relationships) and the number of family members, income to costs ratio

    4. HMV complications due to tracheobronchitis [Up to 1 year]

      Record the number of tracheobronchitis (events) and the number of hospitalizations due to their effects

    5. HMV complications due to ventilator-associated pneumonia [Up to 1 year]

      Record the number of ventilator-associated pneumonias (events) and the number of hospitalizations due to their effects

    6. HMV complications due to the loose tracheostomy [Up to 1 year]

      Record the number of loose tracheostomies (events) and the number of hospitalizations due to their effects

    7. HMV complications due to the granulation-tissue formation at tracheostomy [Up to 1 year]

      Record the number of granulation-tissue formations at tracheostomy (events) and the number of hospitalizations due to their effects

    8. HMV complications due to pneumothorax [Up to 1 year]

      Record the number of pneumothoraces (events) and the number of hospitalizations due to their effects

    9. HMV complications due to the ventilator malfunction [Up to 1 year]

      The number of ventilator malfunctions (events) and the number of hospitalizations due to their effects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All hospitalized patients requiring mechanical ventilation aged 18 or more years.
    Exclusion Criteria:
    • None.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medicine, Faculty of Medicine, Thammasat University Pathumthani Thailand 12120

    Sponsors and Collaborators

    • Thammasat University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Narongkorn Saiphoklang, MD, Assistant Professor, Thammasat University
    ClinicalTrials.gov Identifier:
    NCT02927613
    Other Study ID Numbers:
    • MTU-EC-IM-6-146/57
    First Posted:
    Oct 7, 2016
    Last Update Posted:
    Oct 7, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Narongkorn Saiphoklang, MD, Assistant Professor, Thammasat University

    Study Results

    No Results Posted as of Oct 7, 2016