Effect of the Adjunction of the Double Trunk Mask Above Standard Nasal Cannula
Phase: NA
Conditions: Hypoxia
Sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium

Effect of the adjunction of the Double Trunk Mask above standard 
nasal cannula during acute hypoxia 
5 March 2018 
 
 
 
Study Protocol and Statistical Analysis Plan 
Study Design 
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. 
(Figure 1) 
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. 
 
Participants  
 
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. 
 
 

Effect of the adjunction of the Double Trunk Mask above standard 
nasal cannula during acute hypoxia 
5 March 2018 
 
 
 
Primary Endpoints 
The primary endpoint was the change of PaO2. 
Sequence (Figure 1): The patient should be placed in semi-seated (position at 45 °) 
Patient will be oxygenated with classical nasal cannula. Oxygen flow rate will be adjusted to obtain a 
Saturation in oxygen > at 90%. 
1. Arterial gazometry will be taken after 20 and 60 minutes with NC. 
2. The clinician will associate the Double Trunk Mask (DTM) with the same parameters 
of the nasal cannula. Arterial gazometry will be performed after 20 and 60minutes after placement of 
DTM. 
3. After the withdrawal of DTM, arterial gazometry will be performed after 20 and 60 
minutes 
 
Statistical Analysis 
 
All participants who received this intervention and completed two phases of study were included in 
the efficacy analysis.  
A sample size of 20 participants was needed to provide 90% power to detect a 10 mm Hg difference 
in PaO2. ANOVA for repeated measures followed by a post hoc test will be using to compare the 
difference between participants receiving (CN + DTM) and CN alone. 
The test was performed with a significance level of 0.05 (two-sided). Statistical analyses were 
carried out using SigmaPlot software version 12.0 (Systat Software Inc. UK). 
 
Adverse Event Assessment 
 
Safety was assessed by the number of participants with adverse events (AEs). AEs were collected by 
systematic assessment using terms from the Medical Dictionary for Regulatory Activities (MedDRA), 
version 11.1 in participants who received one or more doses of intervention. Adverse events 
during washout were not collected. 
 
Figure 1 

Effect of the adjunction of the Double Trunk Mask above standard 
nasal cannula during acute hypoxia 
5 March 2018