Oxygen Inhalation Therapy Clinical Trial
Official title:
Effect of a Double Trunk Mask Associated to Nasal Prongs During a High Flow Oxygenation Method
The aim of this study is to determine the effect (on PaO2) of a modified mask associated to nasal cannula used for high flow oxygenation.
Study Design This is a single-center, randomized, blind investigator, 2-way crossover study
design. Enrolled participants had severe hypoxia being treated at Intensive Care Unit
associated with a hospital in Hornu (Epicura).
The study consisted of two intervention periods of 2 weeks separated by a washout period of
20 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 severe 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.
Statistical Analysis
All participants who received this intervention and completed two phases of study were
included in the efficacy analysis.
A sample size of 15 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 were used to
compare the difference between participants receiving (CHFONP + DTM) and CHFONP alone.
The test was performed with a significance level of 0.05 (two-sided). Statistical analyses
were carried out using SigmaPlot software version 11.0 (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.
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