Cardiogenic Pulmonary OedemaNCT02977572
Non-invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema
A study testing Non-Invasive Ventilation and Continuous Positive AirwayPressure CPAP in people with Cardiogenic Pulmonary Oedema, run by Hospital General Universitario de Castellón.
Trial summary
The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV) performs better than a Continuous Positive Airway Pressure (CPAP) in the management of Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Pulmonary Oedema
- What is being tested?
- Non-Invasive Ventilation and Continuous Positive AirwayPressure CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants suffering from CPE, defined as having the presence of dyspnea, respiratory rate >25 breaths/minute, the use of accessory respiratory muscles, cyanosis, cold sweats, bilateral crackles and/or wheezing on pulmonary auscultation, hypoxaemia, hypertension, and a predominance of bilateral pulmonary infiltrates upon a chest radiography (if available).
- The potential causes of CPE have been understood to be Acute Coronary Syndrome (ACS) with or without a persistent ST-segment elevation, hypertensive emergency, valvulopathy, acute arrhythmia, endocarditis, or decompensation due to a chronic heart failure.
Who cannot join
- The exclusion criteria were: a refused consent, the patient's inability to cooperate, severe encephalopathy (Glasgow Coma Score <10)
- Anatomical difficulty when adjusting the face mask, non-cardiogenic Acute Respiratory Failure (pneumonia, blunt chest trauma, or chronic obstructive pulmonary disease)
- Respiratory or cardiac arrest on admission, together with the need for an immediate intubation.
- Specific cardiac contraindications were also considered, including: cardiogenic shock on admission established by systolic blood pressure (SBP) <90 mmHg, or a dependence on vasoactive drugs (norepinephrine >0.5 µg/kg/min).
About this study
Official title: Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit
The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV) performs better than a Continuous Positive Airway Pressure (CPAP) in the management of Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting.
Read the detailed description
Continuous Positive Airway Pressure (CPAP) and Non-Invasive Ventilation (NIV), has played a decisive role in the treatment of Acute Respiratory Failure (ARF) secondary to Cardiogenic Pulmonary Edema (CPE). The use of either CPAP or NIV has resulted in greater clinical improvements than the ones that have been previously obtained by using a standard medical therapy. Although there is a strong indication for NIV in hypercapnic patients, the situation whether NIV is superior to CPAP remains unclear, and hence, both have been recommended.
NIV and CPAP have both been successfully used in patients admitted to an Intensive Care Unit (ICU) suffering from CPE. However, few trials have been published on the ICU scenario. In addition, Acute Coronary Syndrome (ACS) has been considered to be an exclusion criterion in several trials.
At the time of the onset of CPE, either in the Emergency Department (ED) or in the ward, all participants received a standard medical therapy (oxygen through a Venturi mask, morphine, intravenous nitroglycerin if their systolic blood pressure >160 mmHg, together with loop diuretics), all at the discretion of the attending physician. In the absence of a clinical improvement [dyspnea, respiratory rate >25rpm, transcutaneous arterial oxygen saturation (SaO2) <90%], the participant was admitted to the ICU and assigned to the NIV group or the CPAP group, regardless of the treatment that they had received in the ED. The participants that were admitted to the ICU at the onset of CPE were randomised without a trial of medical treatment. The assignment of each group was performed by opening a sealed envelope following a prior randomisation by using a computerised system.
Statistical. A comparative analysis was conducted by using the Student's t-test or the Mann-Whitney test for a comparison of the quantitative variables for the parametric and non-parametric characteristics, respectively. For the qualitative variables, the investigators used the Chi-Square statistic or Fisher's exact test. A statistical significance was reached if P<0.05. The cumulative probability of survival was compared by using a Kaplan-Meier estimation of survival and a Log-Rank Test to compare both of the groups.
- Conditions
- Cardiogenic Pulmonary Oedema
- Being tested
- Non-Invasive Ventilation, Continuous Positive AirwayPressure CPAP
- Keywords
- Non-invasive ventilation,, continuous positive airway pressure, cardiogenic pulmonary oedema,, acute respiratory failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive VentilationDevice
In arm description
Continuous Positive AirwayPressure CPAPDevice
In arm description
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive ventilation (NIV group) | Experimental | 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. Receives: Device: Non-Invasive Ventilation |
| Continuous Positive AirwayPressure CPAP | Placebo comparator | The CPAP was applied by using a flow generator with adjustable fractional inspired oxygen (FiO2). 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 virtual valve. A initial level of 5cmH20 of PEEP was recommended for the first hour of ventilation, 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 it was replaced by a Venturi mask. Receives: Device: Continuous Positive AirwayPressure CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit
Measured: Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit
Secondary outcomes (8)
Duration of the Ventilation
Period of ventilation (either noninvasive ventilation or continouos positive airway pressure) while the patient suffers from acute respiratory failure secondary to cardiopulmonary edema
Measured: Time (hours) from start of ventilation until the removal of both devices because of improve or failure
Ventilator Acquired Pneumonia
Pulmonary infections (%) during stay at intensive care unit
Measured: Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation
Acute Renal Failure
Development of acute renal failure measured as increase of level of creatinine
Measured: Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)
Length of Stay at Intensive Care Unit
Length of stay of the patient at Intensive Care Unit
Measured: Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.
Length of Hospital Stay
All the time (days) the patient stays at the hospital
Measured: Length of stay (days) at hospital at discharge from hospital
Intensive Care Unit Mortality
Mortality (%) at Intensive Care Unit
Measured: Mortality (%) at Intensive Care Unit at discharge from intensive care unit
28th Day Mortality
Mortility of patients within of the first 28 days after randomization (either at intensive car unit or at hospital)
Measured: Mortality within 28 days of randomization
Hospital Mortality
Mortality during hospital stay (including at Intensive care mortality)
Measured: Mortality (%) at Hospital at discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiogenic Pulmonary OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Castellón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALBERTO BELENGUER MUNCHARAZ, Hospital General Universitario de Castellón
- Investigators
- ALBERTO BELENGUER-MUNCHARAZ, MD, Principal investigator, INTENSIVE CARE UNIT. HOSPITAL GENERAL CASTELLO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977572
- Sponsor's protocol ID
- HGU Castellon-002
- Status last verified
- Jun 2017
- First submitted
- 21 Nov 2016
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02977572
- Acronym / sponsor ID
- HGU Castellon-002
- Conditions
- Cardiogenic Pulmonary Oedema
- Keywords
- Non-invasive ventilation,, continuous positive airway pressure, cardiogenic pulmonary oedema,, acute respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hospital General Universitario de CastellónUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Posted 21 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV) performs better than a Continuous Positive Airway Pressure (CPAP) in the management of Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting.
Detailed description
Continuous Positive Airway Pressure (CPAP) and Non-Invasive Ventilation (NIV), has played a decisive role in the treatment of Acute Respiratory Failure (ARF) secondary to Cardiogenic Pulmonary Edema (CPE). The use of either CPAP or NIV has resulted in greater clinical improvements than the ones that have been previously obtained by using a standard medical therapy. Although there is a strong indication for NIV in hypercapnic patients, the situation whether NIV is superior to CPAP remains unclear, and hence, both have been recommended.
NIV and CPAP have both been successfully used in patients admitted to an Intensive Care Unit (ICU) suffering from CPE. However, few trials have been published on the ICU scenario. In addition, Acute Coronary Syndrome (ACS) has been considered to be an exclusion criterion in several trials.
At the time of the onset of CPE, either in the Emergency Department (ED) or in the ward, all participants received a standard medical therapy (oxygen through a Venturi mask, morphine, intravenous nitroglycerin if their systolic blood pressure >160 mmHg, together with loop diuretics), all at the discretion of the attending physician. In the absence of a clinical improvement [dyspnea, respiratory rate >25rpm, transcutaneous arterial oxygen saturation (SaO2) <90%], the participant was admitted to the ICU and assigned to the NIV group or the CPAP group, regardless of the treatment that they had received in the ED. The participants that were admitted to the ICU at the onset of CPE were randomised without a trial of medical treatment. The assignment of each group was performed by opening a sealed envelope following a prior randomisation by using a computerised system.
Statistical. A comparative analysis was conducted by using the Student's t-test or the Mann-Whitney test for a comparison of the quantitative variables for the parametric and non-parametric characteristics, respectively. For the qualitative variables, the investigators used the Chi-Square statistic or Fisher's exact test. A statistical significance was reached if P<0.05. The cumulative probability of survival was compared by using a Kaplan-Meier estimation of survival and a Log-Rank Test to compare both of the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive ventilation (NIV group) | Experimental | Device: Non-Invasive VentilationFor 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. |
| Continuous Positive AirwayPressure CPAP | Placebo comparator | Device: Continuous Positive AirwayPressure CPAPThe CPAP was applied by using a flow generator with adjustable fractional inspired oxygen (FiO2). 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 virtual valve. A initial level of 5cmH20 of PEEP was recommended for the first hour of ventilation, 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 it was replaced by a Venturi mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants suffering from CPE, defined as having the presence of dyspnea, respiratory rate >25 breaths/minute, the use of accessory respiratory muscles, cyanosis, cold sweats, bilateral crackles and/or wheezing on pulmonary auscultation, hypoxaemia, hypertension, and a predominance of bilateral pulmonary infiltrates upon a chest radiography (if available).
- The potential causes of CPE have been understood to be Acute Coronary Syndrome (ACS) with or without a persistent ST-segment elevation, hypertensive emergency, valvulopathy, acute arrhythmia, endocarditis, or decompensation due to a chronic heart failure.
Key exclusion criteria (4 listed)
- The exclusion criteria were: a refused consent, the patient's inability to cooperate, severe encephalopathy (Glasgow Coma Score <10)
- Anatomical difficulty when adjusting the face mask, non-cardiogenic Acute Respiratory Failure (pneumonia, blunt chest trauma, or chronic obstructive pulmonary disease)
- Respiratory or cardiac arrest on admission, together with the need for an immediate intubation.
- Specific cardiac contraindications were also considered, including: cardiogenic shock on admission established by systolic blood pressure (SBP) <90 mmHg, or a dependence on vasoactive drugs (norepinephrine >0.5 µg/kg/min).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive VentilationIn arm description | Device | Non-Invasive ventilation (NIV group) |
| Continuous Positive AirwayPressure CPAPIn arm description | Device | Continuous Positive AirwayPressure CPAP |
Primary outcome
Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit
Time frame: Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit
8 secondary outcomes
Duration of the Ventilation
Time frame: Time (hours) from start of ventilation until the removal of both devices because of improve or failure
Ventilator Acquired Pneumonia
Time frame: Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation
Acute Renal Failure
Time frame: Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)
Length of Stay at Intensive Care Unit
Time frame: Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.
Length of Hospital Stay
Time frame: Length of stay (days) at hospital at discharge from hospital
Intensive Care Unit Mortality
Time frame: Mortality (%) at Intensive Care Unit at discharge from intensive care unit
28th Day Mortality
Time frame: Mortality within 28 days of randomization
Hospital Mortality
Time frame: Mortality (%) at Hospital at discharge from hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALBERTO BELENGUER-MUNCHARAZ, MD principal investigator
INTENSIVE CARE UNIT. HOSPITAL GENERAL CASTELLO
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Ventilation and Continuous Positive AirwayPressure CPAP in people with Cardiogenic Pulmonary Oedema, run by Hospital General Universitario de Castellón.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit (time frame: Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.