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

NCT02927613 | Completed DMC

• 1 other identifier: MTU-EC-IM-6-146/57
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Home Mechanical Ventilation; Prolonged Mechanical Ventilation

Keywords

Home mechanical ventilation; Mortality; Complications; Developing country

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Healthcare home visit

  Up to 1 year

• Caregiver characteristics

  Up to 1 year

• Family characteristics

  Upto 1 year

• HMV complications due to tracheobronchitis

  Up to 1 year

• HMV complications due to ventilator-associated pneumonia

  Up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All hospitalized patients requiring mechanical ventilation.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Department of Medicine, Faculty of Medicine, Thammasat University

Pathum Thani, 12120, Thailand

Location

Related Publications (11)

• 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.

  PMID: 17984626 BACKGROUND

• 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.

  PMID: 21122178 BACKGROUND

• 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.

  PMID: 16354866 BACKGROUND

• 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.

  PMID: 9201051 BACKGROUND

• 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.

  PMID: 21439086 BACKGROUND

• 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.

  PMID: 22059178 BACKGROUND

• 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.

  PMID: 24931271 BACKGROUND

• 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.

  PMID: 25017882 BACKGROUND

• 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.

  PMID: 21883681 BACKGROUND

• 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.

  PMID: 25081652 BACKGROUND

• Simonds AK. Risk management of the home ventilator dependent patient. Thorax. 2006 May;61(5):369-71. doi: 10.1136/thx.2005.055566.

  PMID: 16648349 BACKGROUND

Study Officials

• Narongkorn Saiphoklang, MD

  Faculty of Medicine, Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 7, 2016
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)