Non-Invasive Mechanical Ventilation in Elderly Patients
Primary Purpose
Acute Respiratory Failure
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option
standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed
standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure focused on measuring old patients, NIV, Intubation, COPD
Eligibility Criteria
Inclusion Criteria:
- Age higher 75 years old
- Hypercapnic acute respiratory failure (PaCO2 greater 50 mmHg and pH lower than 7.35)
- Respiratory rate (RR) higher 25 bpm after 12 hours of standard medical therapy.
Exclusion Criteria:
- Respiratory failure due to pulmonary oedema
- Kelly's score equal or higher than 4
- Cardio-respiratory arrest
- Systolic arterial blood pressure greater than 90 mmHg or severe arrhythmia
- Recent facial, oesophageal and gastric surgery
Sites / Locations
- Istituto Scientifico di Pavia Fondazione Salvatore Maugeri
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
standard therapy + oxygen
Outcomes
Primary Outcome Measures
Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate
Secondary Outcome Measures
Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay
Full Information
NCT ID
NCT00600639
First Posted
January 14, 2008
Last Updated
July 16, 2012
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Villa Gaiato, Modena, Ospedale Regionale di Locarno
1. Study Identification
Unique Protocol Identification Number
NCT00600639
Brief Title
Non-Invasive Mechanical Ventilation in Elderly Patients
Official Title
Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Villa Gaiato, Modena, Ospedale Regionale di Locarno
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years.
A multicentric, randomized-controlled trial conduced in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
Detailed Description
Non-invasive mechanical ventilation (NIMV) has been successfully used in Hypercapnic Acute Respiratory Failure (HARF) since endotracheal intubation (ETI) and invasive ventilation are associated to high morbidity and mortality rate.
because of the lack of beds in most Intensive Care Units (ICUs) and the high mortality and cost associated with the increased of age, the "Elderly" patients affected by ARF due to chronic diseases are not always considered for ETI.
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years (see tab1).
Authors MEAN AGE
(yrs) TYPE of STUDY
Bott <80 COPD NIV vs Medical Therapy
Brochard71±9 COPD NIV vs Medical Therapy
Kramer 66±7 COPD NIV vs Medical Therapy
Andeev 63±4 COPD NIV vs Medical Therapy
Barbe 70±2 COPD NIV vs Medical Therapy
Bardi 68±8 COPD NIV vs Medical Therapy
Plant 69±8 COPD NIV vs Medical Therapy
Thys 71±8 COPD NIV vs sham NIV
Nava 68±8 COPD NIV in weaning
Girault 63±14 NIV in weaning
Ferrer 70±7 NIV in weaning
Hill 71±3 COPD PAV vs PSV
Confalonieri 66±14 PNEUMONIA NIV vs Medical Therapy
Martin 64±17 Miscellaneous NIV vs Medical Therapy
Conti 72±7 COPD NIV vs EI
A multicentric, randomized-controlled trial conducted in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
old patients, NIV, Intubation, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
Arm Title
2
Arm Type
Active Comparator
Arm Description
standard therapy + oxygen
Intervention Type
Device
Intervention Name(s)
Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option
Other Intervention Name(s)
BiPAP Vision or any other ICU ventilators with NIV option
Intervention Description
A mode of ventilation that does not require the insertion of the endotracheal tube, since the support is delivered throgh a full face or nasal mask
Intervention Type
Drug
Intervention Name(s)
standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed
Intervention Description
Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed
Intervention Type
Drug
Intervention Name(s)
standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
Intervention Description
oxygen plus medical therapy for ARF
Primary Outcome Measure Information:
Title
Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age higher 75 years old
Hypercapnic acute respiratory failure (PaCO2 greater 50 mmHg and pH lower than 7.35)
Respiratory rate (RR) higher 25 bpm after 12 hours of standard medical therapy.
Exclusion Criteria:
Respiratory failure due to pulmonary oedema
Kelly's score equal or higher than 4
Cardio-respiratory arrest
Systolic arterial blood pressure greater than 90 mmHg or severe arrhythmia
Recent facial, oesophageal and gastric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Nava
Organizational Affiliation
Fondazione Salvatore Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Scientifico di Pavia Fondazione Salvatore Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Non-Invasive Mechanical Ventilation in Elderly Patients
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