Acute Copd Exacerbation, Hypercapnic Respiratory Failure
Conditions
Keywords
High Flow Nasal Cannula, High Flow Nasal Insufflation, High Flow Oxygen Therapy, High Flow Oxygenation
Brief summary
Current evidence suggests a mechanistic and physiological rationale for the use of high flow nasal cannula (HFNC) in acute respiratory hypoxemic failure (AHRF) based on physiological studies in airway models, healthy volunteers and patients with Chronic Obstructive Respiratory Disease (COPD). This is supported by observational studies in patients with AHRF with reductions in a range of respiratory and other physiological parameters. Observational studies also suggest similar intubation rates and lower failure rates with HFNC when compared to non-invasive ventilation (NIV) with improved patient acceptance and tolerance for HFNC. The role of HFNC is less clear in acute hypercapnic respiratory failure. Although non-invasive ventilation is the recommended treatment, it is associated with discomfort, and a significant proportion (up to 25% in some reports) cannot tolerate non-invasive ventilation. Observational reports and limited data from randomized controlled trials suggests that HFNC is effective in treating patients with hypercapnic respiratory failure. We designed this trial to assess whether early application of HFNC in patients with non-severe hypercapnic respiratory failure can correct barometric abnormalities, and prevent progression to non-invasive ventilation or tracheal intubation and mechanical ventilation.
Interventions
DEVICEHigh flow nasal cannula
HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%.
DEVICEConventional low flow oxygenation
Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%.
Sponsors
Hôpital de Verdun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, nor the participants, nor the treating physicians, nor the investigator can be blinded. However, the outcomes will be analyzed an independent statistician blinded to the treatment assignments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients \> 18 years of age * Acute Hypercapnic respiratory failure with pH \< 7.35 and pCO2 \> 45 mmHg
Exclusion criteria
* Pregnant or Breast-Feeding * Patients who cannot read and understand French or English * Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology * Hypercapnia secondary to exacerbation of asthma * Contraindication to NIV * Contraindication to HFNC * Not for escalation to NIV based on a ceiling of care * pH \< 7.15 * GCS 8 or less * Shock defined as systolic \< 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation * Respiratory or cardio-respiratory arrest * Any other indication that requires immediate invasive/non-invasive mechanical ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients progressing to NIV in each cohort | 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Venous blood gas pH | 1 hour, 6 hours, and 24 hours | — |
| Respiratory rate | 1 hour, 6 hours, 24 hours, and daily until study completion | Number of breaths per minute, as documented in the medical chart |
| Heart rate | 1 hour, 6 hours, 24 hours, and daily until study completion | Number of heart beats per minute, as documented in the medical chart |
| Mean arterial pressure | 1 hour, 6 hours, 24 hours, and daily until study completion | Mean arterial pressure, as documented in the medical chart |
| Incidence of intubation | Up to 90 days after enrolment, or until hospital discharge | — |
| Venous blood gas PCO2 | 1 hour, 6 hours, and 24 hours | — |
| In-hospital mortality | Up to 90 days after enrolment, or until hospital discharge | — |
| Intensive care unit length of stay | Up to 90 days after enrolment, or until discharge from the intensive care unit | — |
| Hospital length of stay | Up to 90 days after enrolment, or until hospital discharge | — |
| Patient comfort | 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days | Level of comfort assessed on a visual analogue scale by the patient |
| Shortness of breath | 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days | Severity of the shortness of breath assessed on a visual analogue scale by the patient |
| Admission to the intensive care unit | Up to 90 days after enrolment, or until hospital discharge | — |
Countries
Canada
Contacts
Primary ContactIvan Pavlov, M.D
Outcome results
None listed