Use of Nasal High Flow Oxygen During Breaks of Non-invasive Ventilation for Patients With Hypercapnic Respiratory Failure (HIGH FLOW ACRF)
Hypercapnic Respiratory Failure
About this trial
This is an interventional supportive care trial for Hypercapnic Respiratory Failure focused on measuring Acute on chronic respiratory failure, High-Flow heated and humidified nasal oxygen therapy
Eligibility Criteria
Inclusion criteria
- Adult patients aged 18 or above, admitted to an ICU, an intermediate care or a respiratory care unit;
- Chronic respiratory disease previously documented or strongly suspected on clinical, radiological and blood gazes data and pulmonary function tests, in connection with an obstructive respiratory disease (COPD, emphysema, overlap-syndrome (COPD + obstructive sleep apnoea) or mixed (bronchiectasis, obesity-hypoventilation syndrome))
- Patients requiring NIV for hypercapnic ARF (whatever the precipitating cause) i.e. with clinical signs of moderate to severe respiratory distress : dyspnea and /or respiratory rate > 25/min and/or use of accessory respiratory muscles and/or paradoxical abdominal motion and/or signs of respiratory encephalopathy (sleepiness, asterixis, confusion); and respiratory acidosis on arterial blood gases, defined by pH<7.35 and PaCO2 > 45 mmHg despite the careful supply of oxygen and appropriate therapy that may include bronchodilators, corticosteroids and antibiotics
Exclusion criteria
- Contraindications to NIV;
- Purely restrictive lung disease (thoracic deformity, neuro-muscular pathology) and pure obstructive sleep apnoea (without spirometric disturbance or daytime gas anomaly)
- Immediate need for intubation (respiratory or cardiac arrest);
- Persistent hemodynamic instability (use of vasopressors for > 1 hour);
- Multiple organ failure (score SOFA>6);
- NIV treatement for >3 consecutive hours before admission to ICU, intermediate care, or respiratory care unit and before randomization;
- Anticipated difficulties to conduct NIV (facial trauma or deformation, edentulous patient);
- End stage chronic respiratory insufficiency (defined as use of NIV at home or CPAP treatment at home);
- Long-term use of NIV or CPAP (defined as use of NIV or CPAP treatment at home)
- Non-treated pneumothorax;
- Impossibility to perform subjective assessment of dyspnea and comfort (cognitive impairment);
- Patient under guardianship or trusteeship;
- Pregnancy/breastfeeding;
- Decision to withhold or to withdraw life-sustaining treatments (including intubation)
- Moribund state
- Current participation in another clinical trial with an endpoint related to NIV.
- No affiliation to social security (beneficial or assignee);
- Lack of oral informed consent (express consent) from the patient or relative of appropriate. For those patients that are unable to give written informed consent at the time of enrollment due to the severity of their illness, a process of delayed consent will be used.
Sites / Locations
- Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
HFHO Group
Standard O2 Group
Patients will receive a first NIV session (for 2 hours) with predefined parameters, and ABG will be performed between one and two hours of starting NIV. NIV will be extended according to ABG result (i.e. extended if pH < 7.30). Switch from NIV to oxygen will require predefined criteria. In-between each NIV session, oxygen will be delivered using a high flow nasal cannula, with a flow of 50-60L/min and a FiO2 set to reach a targeted SpO2: 88%≤SpO2 ≤ 92%. Predefined criteria will be used to resume NIV.
NIV will be initiated based on the same criteria and with the same parameters as the HFHO group. ABG will also be performed between one and two hours and NIV extended according to ABG result (i.e. extended if pH < 7.30). Switch from NIV to oxygen will require the same predefined criteria as the HFHO group. In-between each NIV session, oxygen will be delivered using standard low flow O2 to reach the same targeted SpO2: 88% ≤SpO2 ≤ 92%. Similar criteria will be used to resume NIV