High Flow Nasal Cannula Therapy for Early Management of Acute Hypercapnic Cardiogenic Pulmonary Edema in the Emergency Department

Completed

• Conditions: Acute Cardiogenic Pulmonary Edema; Hypercapnic Respiratory Failure
• Interventions: Device: Non invasive ventilation (niv)

• Registration Number: NCT03883555
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-02-01
• Primary Completion: 2016-09-01
• Study Completion: 2016-09-30
• Status Verified: 2019-03
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non invasive ventilation (NIV)	Non invasive ventilation (niv)	Non invasive ventilation (NIV)

Primary Outcome Measures

Name	Time	Method
Change in PaCO2 after a 1-hour treatment session	1 hour	PaCO2 will be measured from standard laboratory arterial blood gas analysis performed at the end of the first 1-hour-treatment session

Secondary Outcome Measures

Name	Time	Method
blood gas (PaO2, pH, SaO2)	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
signs of increased work of breathing	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
comfort	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
Respiratory rate	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
Dyspnea	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
Proportion of patients	at 1 hour	Proportion of patients with a normalized PaCO2 (PaCO2 equal or lower than 45 mmHg),

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France