NIMV01AECB: Optimization of Ventilator Setting for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Sponsor

University of Milan (Other)

Overall Status

Completed

CT.gov ID

NCT01291303

Collaborator

Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT (Other), Valduce Hospital (Other), IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other), Ente Ospedaliero Cantonale, Bellinzona (Other), Azienda Ospedaliera San Gerardo di Monza (Other)

Enrollment

Locations

Arms

Duration (Months)

11.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The analysis of flow and pressure curves generated by ventilators can be useful in the individuation of patient-ventilator asynchrony, notably in COPD patients. To date, however, a real clinical benefit of this approach to optimize ventilator setting has not been proven. The aim of the present study was to compare: optimized ventilation, driven by the analysis of flow and pressure curves, and standard setting (same initial setting, same time at the bedside, same physician, while the ventilator screen was obscured with numerical data always available). The primary aim was the normalization of pH at two hours, whilst secondary aims were change in PaCO2, respiratory rate, patient's tolerance to ventilation (all parameter evaluated at baseline, 30, 120, 360 minutes and 24 hours after the beginning of ventilation). 70 patients (26 females, aged 78±9 years, PaCO2 74±15 mmHg, pH 7.28±0.05, mean±SD) have been enrolled, with no basal difference between the two groups.

Condition or Disease	Intervention/Treatment	Phase
Acute Exacerbation of Chronic Obstructive Airways Disease	Procedure: Optimized ventilation Procedure: Standard ventilation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Optimization of Ventilator Setting by Flow and Pressure Curves Analysis During Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1- optimized ventilation 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.	Procedure: Optimized ventilation Patients, ventilated in pressure support mode, were ventilated with initial setting PEEP and pressure support of 4 and as maximum tolerated cmH2O, inspiratory and expiratory trigger of 5 L/min and 50% of peak inspiratory flow, with changes driven by the analysis of flow and pressure curves; with a FiO2 to reach a SpO2 level between 88 and 92%.
Experimental: 2-standard setting of ventilation 35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.	Procedure: Standard ventilation Patients, ventilated in pressure support mode, were ventilated with standard setting of ventilation: -same initial setting, same time at the bedside (15 minutes at the beginning of NIV, and 5 minutes at each patients' new evaluation) same physician that "optimized ventilation" mode, while the ventilator screen was obscured (numerical data were, however, always available).

Arm

Intervention/Treatment

Experimental: 1- optimized ventilation

35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.

Procedure: Optimized ventilation

Patients, ventilated in pressure support mode, were ventilated with initial setting PEEP and pressure support of 4 and as maximum tolerated cmH2O, inspiratory and expiratory trigger of 5 L/min and 50% of peak inspiratory flow, with changes driven by the analysis of flow and pressure curves; with a FiO2 to reach a SpO2 level between 88 and 92%.

Experimental: 2-standard setting of ventilation

35 COPD patients ventilated for acute exacerbations in NIV with pressure support mode.

Procedure: Standard ventilation

Patients, ventilated in pressure support mode, were ventilated with standard setting of ventilation: -same initial setting, same time at the bedside (15 minutes at the beginning of NIV, and 5 minutes at each patients' new evaluation) same physician that "optimized ventilation" mode, while the ventilator screen was obscured (numerical data were, however, always available).

Outcome Measures

Primary Outcome Measures

arterial pH [2 hours]
The primary outcome was the normalization of arterial pH (=pH≥7.35) at 2 hours from the beginning of non invasive ventilation

Secondary Outcome Measures

carbon dioxide tension in arterial blood (PaCO2) [120, 360 minutes and 24 hours]
carbon dioxide tension (mmHg) in arterial blood measured 12O, 360 minutes and 24 hours after beginning of non invasive ventilation
respiratory rate (RR) [120, 360 minutes and 24 hours after the beginning of ventilation]
respiratory rate (RR) measured 120, 360 minutes and 24 hours after the beginning of non invasive ventilation
patient's tolerance to ventilation [30, 120, 360 minutes and 24 hours after the beginning of ventilation]
The patients tolerance to ventilation was evaluated on a visual analogue scale. This scale has been used and validated in previous studies and has five scores: 1) bad; 2) poor; 3) sufficient; 4) good; and 5) very good.
mortality [30 days]
30-day mortality after beginning of non invasive ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consecutive patients aged > 40 years affected by COPD exacerbation (defined as an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy), and respiratory acidosis (pH < 7.35) that were treated by NIV in addition to standard medical therapy

Exclusion Criteria:

The needing of intubation
The lack of informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria	Bologna	BO	Italy	40138
2	Ospedale Valduce, Emergency Departement	Como	CO	Italy	22100
3	Ospedale Campo di Marte, UO Pneumologia e UTSIR	Lucca	LU	Italy	55100
4	Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital	Milan		Italy	20142
5	Ospedale S. Gerardo, Pneumologia, Università degli Studi di Milano-Bicocca	Monza		Italy	20052
6	Ente Ospedaliero Cantonale, Intensive Care Unit	Bellinzona	Canton Ticino	Switzerland	6500

Sponsors and Collaborators

University of Milan
Ospedale Campo di Marte, UO Pneumologia e UTSIR, Lucca, IT
Valduce Hospital
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Ente Ospedaliero Cantonale, Bellinzona
Azienda Ospedaliera San Gerardo di Monza

Investigators

Study Chair: Stefano Nava, MD, Policlinico S.Orsola Malpighi, Università di Bologna, Pneumologia e Terapia Intensiva Respiratoria Bologna, BO, Italy
Study Director: Fabiano Di Marco, MD, Respiratory Medicine Section, Dipartimento Toraco-Polmonare e Cardiocircolatorio, Università degli Studi di Milano, San Paolo Hospital