Non-Invasive Mechanical Ventilation in Elderly Patients

July 16, 2012 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

76 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborators

Villa Gaiato, Modena
Ospedale Regionale di Locarno

Investigators

  • Principal Investigator: Stefano Nava, Fondazione Salvatore Maugeri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSM2004-78
  • 2004-78

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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