NCT03457363

Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	DTM will be add above NC	After oxygenation by classical nasal cannula, the DTM will be place above NC

Timeline

• Start date: 2018-06-20
• Primary completion: 2018-07-20
• Completion: 2018-11-20
• First posted: 2018-03-07
• Last updated: 2019-07-23

Locations

1 site across 1 country: Belgium