- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927613
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
Status
Completed
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
-
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Pathumthani, Thailand, 12120
- Department of Medicine, Faculty of Medicine, Thammasat University
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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)
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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
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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
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Up to 1 year
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HMV complications due to the loose tracheostomy
Time Frame: Up to 1 year
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Record the number of loose tracheostomies (events) and the number of hospitalizations due to their effects
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Up to 1 year
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HMV complications due to the granulation-tissue formation at tracheostomy
Time Frame: Up to 1 year
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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
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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.
Sponsor
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
- McKim DA, Road J, Avendano M, Abdool S, Cote F, Duguid N, Fraser J, Maltais F, Morrison DL, O'Connell C, Petrof BJ, Rimmer K, Skomro R; Canadian Thoracic Society Home Mechanical Ventilation Committee. Home mechanical ventilation: a Canadian Thoracic Society clinical practice guideline. Can Respir J. 2011 Jul-Aug;18(4):197-215. doi: 10.1155/2011/139769.
- Oktem S, Ersu R, Uyan ZS, Cakir E, Karakoc F, Karadag B, Kiyan G, Dagli E. Home ventilation for children with chronic respiratory failure in Istanbul. Respiration. 2008;76(1):76-81. doi: 10.1159/000110801. Epub 2007 Nov 6.
- Divo MJ, Murray S, Cortopassi F, Celli BR. Prolonged mechanical ventilation in Massachusetts: the 2006 prevalence survey. Respir Care. 2010 Dec;55(12):1693-8.
- MacIntyre NR, Epstein SK, Carson S, Scheinhorn D, Christopher K, Muldoon S; National Association for Medical Direction of Respiratory Care. Management of patients requiring prolonged mechanical ventilation: report of a NAMDRC consensus conference. Chest. 2005 Dec;128(6):3937-54. doi: 10.1378/chest.128.6.3937.
- Kurek CJ, Cohen IL, Lambrinos J, Minatoya K, Booth FV, Chalfin DB. Clinical and economic outcome of patients undergoing tracheostomy for prolonged mechanical ventilation in New York state during 1993: analysis of 6,353 cases under diagnosis-related group 483. Crit Care Med. 1997 Jun;25(6):983-8. doi: 10.1097/00003246-199706000-00015.
- Lone NI, Walsh TS. Prolonged mechanical ventilation in critically ill patients: epidemiology, outcomes and modelling the potential cost consequences of establishing a regional weaning unit. Crit Care. 2011;15(2):R102. doi: 10.1186/cc10117. Epub 2011 Mar 27.
- Sanjuan-Lopez P, Valino-Lopez P, Ricoy-Gabaldon J, Verea-Hernando H. Amyotrophic lateral sclerosis: impact of pulmonary follow-up and mechanical ventilation on survival. A study of 114 cases. Arch Bronconeumol. 2014 Dec;50(12):509-13. doi: 10.1016/j.arbres.2014.04.010. Epub 2014 Jun 12. English, Spanish.
- Tagami M, Kimura F, Nakajima H, Ishida S, Fujiwara S, Doi Y, Hosokawa T, Yamane K, Unoda K, Hirose T, Tani H, Ota S, Ito T, Sugino M, Shinoda K, Hanafusa T. Tracheostomy and invasive ventilation in Japanese ALS patients: decision-making and survival analysis: 1990-2010. J Neurol Sci. 2014 Sep 15;344(1-2):158-64. doi: 10.1016/j.jns.2014.06.047. Epub 2014 Jul 1.
- Heinemann F, Budweiser S, Jorres RA, Arzt M, Rosch F, Kollert F, Pfeifer M. The role of non-invasive home mechanical ventilation in patients with chronic obstructive pulmonary disease requiring prolonged weaning. Respirology. 2011 Nov;16(8):1273-80. doi: 10.1111/j.1440-1843.2011.02054.x.
- Hazenberg A, Kerstjens HA, Prins SC, Vermeulen KM, Wijkstra PJ. Initiation of home mechanical ventilation at home: a randomised controlled trial of efficacy, feasibility and costs. Respir Med. 2014 Sep;108(9):1387-95. doi: 10.1016/j.rmed.2014.07.008. Epub 2014 Jul 22.
- Simonds AK. Risk management of the home ventilator dependent patient. Thorax. 2006 May;61(5):369-71. doi: 10.1136/thx.2005.055566.
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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