An observational study in Acute Cardiogenic Pulmonary Edema and Hypercapnic Respiratory Failure, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by University Hospital, Montpellier · Observational
High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 32 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients admitted for acute respiratory failure secondary to acute cardiogenic lung edema with hypercapnia
a suspected diagnosis of acute cardiogenic pulmonary edema presenting with any of the following criteria:
signs of respiratory failure or any of the following clinical, laboratory or radiology signs:
hypercapnia (PaCO2>45 mmHg at arterial blood gas analysis)
Exclusion criteria:
High flow nasal therapy (HFNT)
Device: High flow nasal therapy (HFNT) : Optiflow™
Non invasive ventilation (NIV)
Device: Non invasive ventilation (niv)
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
Also known as: High flow nasal cannula, High flow nasal oxygen, Optiflow™
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
PaCO2 will be measured from standard laboratory arterial blood gas analysis performed at the end of the first 1-hour-treatment session
Time frame: 1 hour
blood gas (PaO2, pH, SaO2)
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
Time frame: at 1 hour
Respiratory rate
Respiratory rate, measured over 1-min as part of standard clinical assessment after each 1h ventilatory support session and throughout ventilatory support
Time frame: at 1 hour
signs of increased work of breathing
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
Time frame: at 1 hour
Dyspnea
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
Time frame: at 1 hour
comfort
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
Time frame: at 1 hour
Proportion of patients
Proportion of patients with a normalized PaCO2 (PaCO2 equal or lower than 45 mmHg),
Time frame: at 1 hour
Plan to share: Undecided
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier