Clinical trial NCT00600639: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Respiratory Failure
Keywords: old patients
NIV
Intubation
COPD
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: Villa Gaiato, Modena
name: Ospedale Regionale di Locarno
First posted: 2008-01-25
Enrollment: 82
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay
timeFrame: 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituto Scientifico di Pavia Fondazione Salvatore Maugeri
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Stefano Nava
role: PRINCIPAL_INVESTIGATOR
References: