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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Trunk Mask | Experimental | DTM will be add above nasal cannula |
|
| Nasal Cannula Alone | Active Comparator | Patients receive oxygen only thought nasal Cannula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTM will be add above NC | Device | After oxygenation by classical nasal cannula, the DTM will be place above NC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation | we will observe effect of adjunction of a DTM on PaO2 | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| PaCO2 | we will observe the effect of the addition of the DTM on PaCO2 | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epicura | Hornu | Hainaut | 7301 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26566938 | Background | 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. | |
| 15871753 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 5, 2018 | Mar 5, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2018 | Mar 5, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2018 | Mar 5, 2018 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Comparison of level oxygenation between classical oxygenation with nasal canulae with or without adjunctive of a double trunk mask
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| 6476597 | Background | 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. |