Trial Outcomes & Findings for Non-invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema (NCT NCT02977572)

For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

For the Non-Invasive ventilation group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

The Continuous Positive Airway Pressure was applied by using a flow generator that was capable of delivering a flow of 140 Liter/minute, with adjustable fractional inspired oxygen that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=110 Participants

Total of all reporting groups

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description

n=56 Participants

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Non-Invasive Ventilation: In arm description

n=54 Participants

The CPAP was applied by using a flow generator that was capable of delivering a flow of 140 Liter /minute, with adjustable fractional inspired oxygen (FiO2) that ranged from 0.3 to 1.0. This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a turbulence which creates a virtual valve. A minimal initial level of 5cmH20 of PEEP was recommended for the first hour of the CPAP, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4. Continuous Positive Airway Pressure: In arm description