Hypoxia
Conditions
Keywords
oxygen, nasal cannula, double trunk mask, hypoxia
Brief summary
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with severe hypoxia.
Detailed description
This is a single-center, randomized, blind investigator, 2-way crossover study design. Enrolled participants had hypoxia being treated at Intensive Care Unit associated with a hospital in Hornu (Epicura). The study consisted of two intervention periods separated by a washout period of 30 minutes. The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with hypoxia. The protocol and informed consent documents were reviewed and approved by a recognized ethics review board at the study facility. The study was performed in accordance with the Declaration of Helsinki.
Interventions
DEVICEDTM will be add above NC
After oxygenation by classical nasal cannula, the DTM will be place above NC
Sponsors
Laboratory of Movement, Condorcet, Tournai, Belgium
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparison of level oxygenation between classical oxygenation with nasal canulae with or without adjunctive of a double trunk mask
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Regardless of gender, at least 18 years of age and diagnosed with Hypoxia (PaO2/FiO2 \< 380 mm Hg), dyspnea, respiratory rate (RR) ≥ 25 CPM, PaCO2 ≤ 45 mmHg, patient with an arterial catheter and without hemodynamic instability, Glasgow Coma Scale ≥ 12/15, written consent. Participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel.
Exclusion criteria
* Patients were excluded if they Hypercapnia (\> 45 mm Hg with respiratory acidosis), COPD, pulmonary fibrosis, hypoventilation obesity syndrome, arterial pressure \< 60 mm Hg or treatment by epinephrine \> to 0,1 gamma/kg/minute, deterioration of awareness (Glasgow scale \< or = 12), acute confusional state. Participants were randomized in a 1:1 ratio to receive either classical oxygenation with nasal cannula (NC) for 20 minutes or NC with an adjunctive of a Double Trunk Mask.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation | 30 minutes | we will observe effect of adjunction of a DTM on PaO2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PaCO2 | 30 minutes | we will observe the effect of the addition of the DTM on PaCO2 |
Countries
Belgium
Outcome results
None listed