Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia
Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia
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.
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.
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.