Status:
COMPLETED
Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia
Lead Sponsor:
Laboratory of Movement, Condorcet, Tournai, Belgium
Conditions:
Hypoxia
Eligibility:
All Genders
18+ years
Phase:
NA
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 (Epicu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03457363
Start Date
June 20 2018
End Date
November 20 2018
Last Update
July 23 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Epicura
Hornu, Hainaut, Belgium, 7301