Non-Invasive Mechanical Ventilation in Elderly Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Respiratory Failure in Older Patients	Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option Drug: 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	Phase IV

MedlinePlus related topics:

Antibiotics

Drug Information available for:

Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate Salicylsalicylic acid Sodium salicylate Isoetharine Isoetharine hydrochloride Isoetharine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Fondazione Salvatore Maugeri:

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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	82
Study Start Date:	January 2004
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option	Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option 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 Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed
2: Active Comparator standard therapy + oxygen	Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed oxygen plus medical therapy for ARF

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

Ages Eligible for Study:	76 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600639

Locations


Italy
	Istituto Scientifico di Pavia Fondazione Salvatore Maugeri
	Pavia, Italy, 27100

Sponsors and Collaborators

Fondazione Salvatore Maugeri

Villa Gaiato, Modena

Ospedale Regionale di Locarno

Investigators


Principal Investigator:	Stefano Nava	Fondazione Salvatore Maugeri

More Information

Responsible Party:	( Fondazione S.Maugeri )
Study ID Numbers:	FSM2004-78, 2004-78
First Received:	January 14, 2008
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00600639
Health Authority:	Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:

old patients

NIV

Intubation

COPD

Study placed in the following topic categories:

Hypercapnia

Methylprednisolone

Albuterol

Respiration Disorders

Salicylsalicylic acid

Hypoventilation

Sodium Salicylate

Methylprednisolone acetate

Prednisolone acetate

Signs and Symptoms

Respiratory Insufficiency

Respiratory Tract Diseases

Prednisolone

Signs and Symptoms, Respiratory

Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Reproductive Control Agents

Hormones

Neuroprotective Agents

Adrenergic Agonists

Tocolytic Agents

Therapeutic Uses

Adrenergic beta-Agonists

Antineoplastic Agents, Hormonal

Gastrointestinal Agents

Anti-Asthmatic Agents

Protective Agents

Glucocorticoids

Pharmacologic Actions

Autonomic Agents

Peripheral Nervous System Agents

Bronchodilator Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 28, 2008

Sponsors and Collaborators:	Fondazione Salvatore Maugeri Villa Gaiato, Modena Ospedale Regionale di Locarno
Information provided by:	Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:	NCT00600639