High Flow Nasal Cannula, Hypercapnia, Sedation Complication
Conditions
Keywords
High Flow Nasal Cannula, Sedation, Dead space ventilation
Brief summary
High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing. This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent. A randomized, double-blinded, cross-over study is designed.
Interventions
DEVICETHRIVE (High Flow Nasal Cannula)
2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen
Sponsors
Fisher and Paykel Healthcare
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patient is sedated and the investigators are blinded for the randomization. Only the care provider is aware of the randomisation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with COPD Gold classification 3 or 4 * Scheduled EBUS with sedation
Exclusion criteria
* Known neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis, dementia, Multiple Sclerosis or Guillain-Barré. * Allergy or intolerance for propofol or esketamine * Severe pulmonary hypertension (PAPsyst \> 60 mmHg) * Pregnancy * upper airway obstruction, such as subglottic stenosis or obstructing tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slope of capnography at 45 minutes | At t=45 minutes | Angle of the D-E segment (inspiratory slope) |
| Slope of capnography at 10 minutes (baseline) | At t=10 minutes | Angle of the D-E segment (inspiratory slope) |
| Slope of capnography at 25 minutes | At t=25 minutes | Angle of the D-E segment (inspiratory slope) |
| Inspiratory CO2 at 10 minutes (baseline) | at t=10 minutes | Inspiratory CO2, measured at the carinal level |
| Inspiratory CO2 at 25 minutes | at=25 minutes | Inspiratory CO2, measured at the carinal level |
| Inspiratory CO2 at 45 minutes | at t=45 minutes | Inspiratory CO2, measured at the carinal level |
| expiratory CO2 at 10 minutes (baseline) | at t=10 minutes | Expiratory CO2, measured at the carinal level |
| expiratory CO2 at 25 minutes | at t=25 minutes | Expiratory CO2, measured at the carinal level |
| expiratory CO2 at 45 minutes | t=45 minutes | Expiratory CO2, measured at the carinal level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The level of HFNC dead space washout | At t=10 minutes | Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level. |
| Respiratory rate | At t=10 minutes | Respiratory rate, measured by capnography |
Countries
Netherlands
Outcome results
None listed