Non-Invasive Mechanical Ventilation in Elderly Patients
Information source: Fondazione Salvatore Maugeri
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Respiratory Failure in Older Patients
Intervention: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option (Device); standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed (Drug); standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Fondazione Salvatore Maugeri Official(s) and/or principal investigator(s):
Stefano Nava, Principal Investigator, Affiliation: Fondazione Salvatore Maugeri
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Arterial Blood Gasses improvement
Clinical improvement (decrease of respiratory rate and dyspnoea value)
Length of Hospital stay
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.
Eligibility
Minimum age: 76 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Istituto Scientifico di Pavia Fondazione Salvatore Maugeri, Pavia 27100, Italy
Additional Information
Starting date: January 2004
Ending date: December 2007
Last updated: January 24, 2008
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