Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of the Adjunction of the Double Trunk Mask Above Standard Nasal Cannula

Conditions
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Hypoxia

Intervention / Treatment
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* Device: DTM will be add above NC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Comparison of level oxygenation between classical oxygenation with nasal canulae with or without adjunctive of a double trunk mask
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double Trunk Mask<br>DTM will be add above nasal cannula | Device: DTM will be add above NC<br>* After oxygenation by classical nasal cannula, the DTM will be place above NC<br>|
| Active Comparator: Nasal Cannula Alone<br>Patients receive oxygen only thought nasal Cannula | Device: DTM will be add above NC<br>* After oxygenation by classical nasal cannula, the DTM will be place above NC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation | we will observe effect of adjunction of a DTM on PaO2 | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaCO2 | we will observe the effect of the addition of the DTM on PaCO2 | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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double trunk mask, hypoxia, oxygen, nasal cannula