Home Mechanical VentilationNCT02927613
Patient Characteristics, Feasibility, and Outcomes of a Home Mechanical Ventilation Program in a Developing Country
An observational study of Home Mechanical Ventilation and Prolonged Mechanical Ventilation, run by Thammasat University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Mechanical Ventilation, Prolonged Mechanical Ventilation
- How many people
- 12 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All hospitalized patients requiring mechanical ventilation.
Who may be able to join
- All hospitalized patients requiring mechanical ventilation aged 18 or more years.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Faculty of Medicine, Thammasat University
Pathum Thani, 12120
About this study
This study aims to describe the patient characteristics, feasibility, and outcomes of an home mechanical ventilation (HMV) program at a university hospital in Thailand.
Read the 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.
- Keywords
- Home mechanical ventilation, Mortality, Complications, Developing country
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate of HMV patients
The number of deaths among HMV patients is recorded during follow-up period (up to 1 year)
Measured: Up to 1 year
Secondary outcomes (9)
Healthcare home visit
Record the number of healthcare home visits (events)
Measured: Up to 1 year
Caregiver characteristics
Record the number of caregivers per patient, the number of well-trained caregivers
Measured: Up to 1 year
Family characteristics
Record types (relationships) and the number of family members, income to costs ratio
Measured: Upto 1 year
HMV complications due to tracheobronchitis
Record the number of tracheobronchitis (events) and the number of hospitalizations due to their effects
Measured: Up to 1 year
HMV complications due to ventilator-associated pneumonia
Record the number of ventilator-associated pneumonias (events) and the number of hospitalizations due to their effects
Measured: Up to 1 year
HMV complications due to the loose tracheostomy
Record the number of loose tracheostomies (events) and the number of hospitalizations due to their effects
Measured: Up to 1 year
HMV complications due to the granulation-tissue formation at tracheostomy
Record the number of granulation-tissue formations at tracheostomy (events) and the number of hospitalizations due to their effects
Measured: Up to 1 year
HMV complications due to pneumothorax
Record the number of pneumothoraces (events) and the number of hospitalizations due to their effects
Measured: Up to 1 year
HMV complications due to the ventilator malfunction
The number of ventilator malfunctions (events) and the number of hospitalizations due to their effects
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Home Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongkorn Saiphoklang, MD, Thammasat University
- Investigators
- Narongkorn Saiphoklang, MD, Principal investigator, Faculty of Medicine, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927613
- Sponsor's protocol ID
- MTU-EC-IM-6-146/57
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 17984626Divo MJ, Murray S, Cortopassi F, Celli BR. Prolonged mechanical ventilation in Massachusetts: the 2006 prevalence survey. Respir Care. 2010 Dec;55(12):1693-8.
PubMed 21122178MacIntyre 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.
PubMed 16354866Kurek 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.
PubMed 9201051Lone 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.
PubMed 21439086McKim 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.
PubMed 22059178Sanjuan-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.
PubMed 24931271Tagami 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.
PubMed 25017882Heinemann 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.
PubMed 21883681Hazenberg 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.
PubMed 25081652Simonds AK. Risk management of the home ventilator dependent patient. Thorax. 2006 May;61(5):369-71. doi: 10.1136/thx.2005.055566.
PubMed 16648349
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics, Feasibility, and Outcomes of a Home Mechanical Ventilation Program in a Developing Country
- ClinicalTrials.gov ID
- NCT02927613
- Acronym / sponsor ID
- MTU-EC-IM-6-146/57
- Keywords
- Home mechanical ventilation, Mortality, Complications, Developing country
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to describe the patient characteristics, feasibility, and outcomes of an home mechanical ventilation (HMV) program at a university hospital in Thailand.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All hospitalized patients requiring mechanical ventilation.
Key inclusion criteria (1 listed)
- All hospitalized patients requiring mechanical ventilation aged 18 or more years.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
9 secondary outcomes
Healthcare home visit
Time frame: Up to 1 year
Caregiver characteristics
Time frame: Up to 1 year
Family characteristics
Time frame: Upto 1 year
HMV complications due to tracheobronchitis
Time frame: Up to 1 year
HMV complications due to ventilator-associated pneumonia
Time frame: Up to 1 year
HMV complications due to the loose tracheostomy
Time frame: Up to 1 year
HMV complications due to the granulation-tissue formation at tracheostomy
Time frame: Up to 1 year
HMV complications due to pneumothorax
Time frame: Up to 1 year
HMV complications due to the ventilator malfunction
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Background: PubMed 17984626Oktem 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.
- Background: PubMed 21122178Divo MJ, Murray S, Cortopassi F, Celli BR. Prolonged mechanical ventilation in Massachusetts: the 2006 prevalence survey. Respir Care. 2010 Dec;55(12):1693-8.
- Background: PubMed 16354866MacIntyre 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.
- Background: PubMed 9201051Kurek 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.
- Background: PubMed 21439086Lone 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.
- Background: PubMed 22059178McKim 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.
- Background: PubMed 24931271Sanjuan-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.
- Background: PubMed 25017882Tagami 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.
- Background: PubMed 21883681Heinemann 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.
- Background: PubMed 25081652Hazenberg 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.
- Background: PubMed 16648349Simonds AK. Risk management of the home ventilator dependent patient. Thorax. 2006 May;61(5):369-71. doi: 10.1136/thx.2005.055566.
- Individual participant dataSharing planned: Yes
Related trials for Home Mechanical Ventilation
Not yet recruitingObservational study
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Amyotrophic Lateral Sclerosis, Home Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narongkorn Saiphoklang, MD principal investigator
Faculty of Medicine, Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Mechanical Ventilation and Prolonged Mechanical Ventilation, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate of HMV patients (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927613, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.