High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department (preopticap)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03883555|
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 25, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Acute Cardiogenic Pulmonary Edema Hypercapnic Respiratory Failure||Device: High flow nasal therapy (HFNT) : Optiflow™ Device: Non invasive ventilation (niv)|
This is a prospective observational study conducted as a preliminary study to the randomized controlled OPTICAP trial (NCT02874339).
Prospective observational exploratory study including ED patients with a suspected diagnosis of acute hypercapnic respiratory failure related to cardiogenic pulmonary edema who require NIV according to the joint recommendations from the French society of anaesthesia and intensive care and the French society for intensive care.
Patients will receive a 1hr treatment session by either NIV or HFNT, depending on the attending ED physician expertise in using HFNT Repeat evaluation of arterial blood gases and respiratory parameters and dyspnea will be performed before and after treatment sessions according to current guidelines.
Improvement in PaCO2 and other respiratory parameters after 1hr treatment by HFNT will be analysed and compared to that of NIV.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||September 1, 2016|
|Actual Study Completion Date :||September 30, 2016|
High flow nasal therapy (HFNT)
Device: High flow nasal therapy (HFNT) : Optiflow™
HFNT will be administered through a heated humidifier (Airvo 2, Fisher and Paykel healthcare) and applied through large bore binasal prongs.
Initial gas flow rate will be set at of 60 l/min and adjusted to 40-50 l/min based on patient's tolerance. FiO2 will be adjusted to maintain an SpO2 ≥ 92%. Initial temperature will be set at 37° and reduced according to patient's tolerance
Non invasive ventilation (NIV)
Non invasive ventilation (NIV)
Device: Non invasive ventilation (niv)
NIV will be delivered through a face mask connected to a dedicated ventilator with pressure support applied in a noninvasive ventilation mode (Monnal T75, Airliquide Medical Systems, Antony, France).
The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 ≥92% and to patient's comfort.
- Change in PaCO2 after a 1-hour treatment session [ Time Frame: 1 hour ]PaCO2 will be measured from standard laboratory arterial blood gas analysis performed at the end of the first 1-hour-treatment session
- blood gas (PaO2, pH, SaO2) [ Time Frame: at 1 hour ]blood gas (PaO2, pH, SaO2) measured from standard laboratory arterial blood gas analysis at the end of each 1h-ventilatory support session and throughout ventilatory support
- Respiratory rate [ Time Frame: at 1 hour ]Respiratory rate, measured over 1-min as part of standard clinical assessment after each 1h ventilatory support session and throughout ventilatory support
- signs of increased work of breathing [ Time Frame: at 1 hour ]signs of increased work of breathing assessed based on patient's use of accessory respiratory muscles and paradoxical abdominal movement and measured using 5-point likert scales ranging from 1 to 5. Signs of increased work of berthing will be assessed at the end of each 1h ventilatory support sessions throughout ventilatory support
- Dyspnea [ Time Frame: at 1 hour ]
Dyspnea recorded by the patient using a Modified Borg scale ranging from 0 to 10.
Dyspnea will be measured at the end of each 1h ventilatory support sessions and throughout ventilatory support
- comfort [ Time Frame: at 1 hour ]Comfort recorded by the patient using a visual analog scale from 0 to 10. Comfort will be assessed at the end of each 1h ventilatory support sessions and throughout ventilatory support
- Proportion of patients [ Time Frame: at 1 hour ]Proportion of patients with a normalized PaCO2 (PaCO2 equal or lower than 45 mmHg),
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
a suspected diagnosis of acute cardiogenic pulmonary edema presenting with any of the following criteria:
- dyspnea (orthopnea or a worsening of dyspnea according to NYHA criteria)
- respiratory rate >20 b/min
- bilateral crepitant rales at pulmonary auscultation
- pulmonary infiltrate on chest X-ray
signs of respiratory failure or any of the following clinical, laboratory or radiology signs:
- Use of accessory respiratory muscles or paradoxical abdominal movement
- Cardiomegaly (cardiothoracic ratio >0.5)
- Hypertensive crisis
- PaO2/FiO2 ≤ 300 mmHg breathing O2> 8L/min or PaO2 ≤ 63mmHg breathing room air
hypercapnia (PaCO2>45 mmHg at arterial blood gas analysis)
- acute exacerbation of chronic obstructive pulmonary disease or associated dyspnea from non cardiac origin
- Fever (>38,5°), sepsis or ongoing infection
- Contra-indication to NIV
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883555
|Montpellier, France, 34295|
|Principal Investigator:||Mustapha Sebbane, MD, PhD||University Hospital, Montpellier|
|Responsible Party:||University Hospital, Montpellier|
|Other Study ID Numbers:||
|First Posted:||March 21, 2019 Key Record Dates|
|Last Update Posted:||March 25, 2019|
|Last Verified:||March 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute cardiogenic pulmonary
High flow nasal oxygen
Non invasive ventilation
Respiratory Tract Diseases
Signs and Symptoms, Respiratory