Non-Invasive Mechanical Ventilation in Elderly Patients

Phase 4

Terminated

• Conditions: Acute Respiratory Failure
• Interventions: Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option; Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed; Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed

• Registration Number: NCT00600639
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-01-25
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option	non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
1	standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed	non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
2	standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed	standard therapy + oxygen

Primary Outcome Measures

Name	Time	Method
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	3 months

Secondary Outcome Measures

Name	Time	Method
Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay	3 months

Trial Locations

Locations (1)

Istituto Scientifico di Pavia Fondazione Salvatore Maugeri; 🇮🇹 Pavia, Italy