Non-Invasive Mechanical Ventilation in Elderly Patients

This study has been terminated.
Sponsor:
Collaborators:
Villa Gaiato, Modena
Ospedale Regionale di Locarno
Information provided by:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT00600639
First received: January 14, 2008
Last updated: July 16, 2012
Last verified: January 2008
  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
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

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
Experimental: 1
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
Other Name: BiPAP Vision or any other ICU ventilators with NIV option
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
Active Comparator: 2
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
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Villa Gaiato, Modena
Ospedale Regionale di Locarno
Investigators
Principal Investigator: Stefano Nava Fondazione Salvatore Maugeri
  More Information

No publications provided

Responsible Party: Fondazione S.Maugeri
ClinicalTrials.gov Identifier: NCT00600639     History of Changes
Other Study ID Numbers: FSM2004-78, 2004-78
Study First Received: January 14, 2008
Last Updated: July 16, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
old patients
NIV
Intubation
COPD

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Hypoventilation
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Albuterol
Methylprednisolone
Anti-Bacterial Agents
Antibiotics, Antitubercular
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents

ClinicalTrials.gov processed this record on April 17, 2014