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Last 3 Months of Life in Home Ventilated Patients

This study has been completed.
Information provided by (Responsible Party):
Michele Vitacca, Fondazione Salvatore Maugeri Identifier:
First received: October 31, 2007
Last updated: February 3, 2016
Last verified: October 2007
To verify with a specific questionnaire, the families' perceived quality of end-of-life care and of dying in the last 3 months of life of 168 patients (Chronic Obstructive Pulmonary Disease-Amyotrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease- others) with chronic respiratory failure needing domiciliary mechanical ventilation (MV).

Condition Intervention
Respiratory Failure
Other: survey administration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Italian Multicenter Survey on the Last 3 Months of Life in Patients Ventilated at Home

Resource links provided by NLM:

Further study details as provided by Michele Vitacca, Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • level of family burden [ Time Frame: 3 months after patient's death ]

Secondary Outcome Measures:
  • influence of diagnosis and modality of ventilation [ Time Frame: 3 months after patient's death ]

Enrollment: 180
Study Start Date: January 2005
Study Completion Date: April 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
family burden
chronich respiratory failure home ventilated patients
Other: survey administration
application of a family survey on last 3 months of life for their relatives under HMV
Other Name: caregiver burden

Detailed Description:

Participants: 168 patients' relatives presenting five categories of diseases (Chronic Obstructive Pulmonary Disease-Amyothrophic Lateral Sclerosis (ALS)-Restrictive disorders-Neuromuscular disease- others) answered to questionnaire.

Interventions: none Measurements and Main Results: 35 questions grouped in 6 specific domains (Control of pain and symptoms (domain 1-D1), awareness of disease (D2), family burden (D3), the process of dying (D4), medical troubles including hospitalizations (D5) and technical problems linked to MV(D6) were asked after the patient's death to a family member by means of a face to face interview. Answers to the binary 35-item questionnaire were distributed into just two clusters per each domain.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Home MV patients in the last 3 months of life

Inclusion criteria:

All patients mechanically ventilated at home who died

Exclusion criteria:

patients with cancer

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Please refer to this study by its identifier: NCT00553046

FSM Respiratory Unit
Lumezzane, BS, Italy, 25065
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Principal Investigator: michele vitacca, MD Fondazione S. Maugeri IRCCS
  More Information

Vitacca M, Comini L & Barbano L. Home mechanical ventilation difficulties in the last 3 months of life as reported by caregivers. J Med Pers 11:30-36, 2013. DOI 10.1007/s12682-012-0128-8

Responsible Party: Michele Vitacca, Principal Investigator, Fondazione Salvatore Maugeri Identifier: NCT00553046     History of Changes
Other Study ID Numbers: N°159
Study First Received: October 31, 2007
Last Updated: February 3, 2016

Keywords provided by Michele Vitacca, Fondazione Salvatore Maugeri:
end of life
mechanical ventilation
CRF home ventilated patients

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases processed this record on May 25, 2017