Status:
COMPLETED
Use of Nasal High Flow Oxygen During Breaks of Non-invasive Ventilation for Patients With Hypercapnic Respiratory Failure
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Direction Générale de l'Offre de Soins
Conditions:
Hypercapnic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic respiratory insufficiency and COPD are the third leading cause of death worldwide. Patients decompensate at various stages of their disease and exhibit acute-on-chronic respiratory failure (AC...
Detailed Description
In both groups, treatment will start with a first NIV session of 2 hours, with arterial blood gas measurement between one hour and two hours after initiating the NIV session. The NIV will be extended ...
Eligibility Criteria
Inclusion
- 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 (without any interruption) 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 and life expectancy below 6 month);
- 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);
- Refusal to participate to the study (patient or legal representative or family member or close relative if present
Exclusion
Key Trial Info
Start Date :
May 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2023
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT03406572
Start Date
May 18 2018
End Date
August 18 2023
Last Update
September 6 2023
Active Locations (1)
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1
Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier
Colombes, France, 92700