Clinical trial NCT03457363: Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia
Official title: Effect of the Adjunction of the Double Trunk Mask Above Standard Nasal Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: oxygen
nasal cannula
double trunk mask
hypoxia
Lead sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Comparison of level oxygenation between classical oxygenation with nasal canulae with or without adjunctive of a double trunk mask
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygenation
timeFrame: 30 minutes
Secondary outcomes:
measure: PaCO2
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Hornu
country: Belgium
facility: Epicura
state: Hainaut
Study officials:
References:
citation: Oude Nijhuis JC, Haane DY, Koehler PJ. A review of the current and potential oxygen delivery systems and techniques utilized in cluster headache attacks. Cephalalgia. 2016 Sep;36(10):970-9. doi: 10.1177/0333102415616878. Epub 2015 Nov 12.
citation: Wettstein RB, Shelledy DC, Peters JI. Delivered oxygen concentrations using low-flow and high-flow nasal cannulas. Respir Care. 2005 May;50(5):604-9.
citation: Tiep BL, Nicotra B, Carter R, Belman MJ, Mittman C. Evaluation of a low-flow oxygen-conserving nasal cannula. Am Rev Respir Dis. 1984 Sep;130(3):500-2. doi: 10.1164/arrd.1984.130.3.500.