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

Prolonged Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927613
• Other study ID #: MTU-EC-IM-6-146/57
• Status: Completed
• Phase: N/A
• First received: September 30, 2016
• Last updated: October 5, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Home Mechanical Ventilation
• Prolonged Mechanical Ventilation

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine, Thammasat University	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

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. — View Citation

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. — View Citation

Heinemann F, Budweiser S, Jörres RA, Arzt M, Rösch 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Nov 6. — View Citation

Sanjuán-López P, Valiño-López P, Ricoy-Gabaldón 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. — View Citation

Simonds AK. Risk management of the home ventilator dependent patient. Thorax. 2006 May;61(5):369-71. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate of HMV patients	The number of deaths among HMV patients is recorded during follow-up period (up to 1 year)	Up to 1 year	No
Secondary	Healthcare home visit	Record the number of healthcare home visits (events)	Up to 1 year	No
Secondary	Caregiver characteristics	Record the number of caregivers per patient, the number of well-trained caregivers	Up to 1 year	No
Secondary	Family characteristics	Record types (relationships) and the number of family members, income to costs ratio	Upto 1 year	No
Secondary	HMV complications due to tracheobronchitis	Record the number of tracheobronchitis (events) and the number of hospitalizations due to their effects	Up to 1 year	No
Secondary	HMV complications due to ventilator-associated pneumonia	Record the number of ventilator-associated pneumonias (events) and the number of hospitalizations due to their effects	Up to 1 year	No
Secondary	HMV complications due to the loose tracheostomy	Record the number of loose tracheostomies (events) and the number of hospitalizations due to their effects	Up to 1 year	No
Secondary	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	Up to 1 year	Yes
Secondary	HMV complications due to pneumothorax	Record the number of pneumothoraces (events) and the number of hospitalizations due to their effects	Up to 1 year	No
Secondary	HMV complications due to the ventilator malfunction	The number of ventilator malfunctions (events) and the number of hospitalizations due to their effects	Up to 1 year	No