Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457363
• Other study ID #: Duprezbruyneel
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: July 2019
• Source: Laboratory of Movement, Condorcet, Tournai, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• DTM will be add above NC
After oxygenation by classical nasal cannula, the DTM will be place above NC

Locations

Country	Name	City	State
Belgium	Epicura	Hornu	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
Laboratory of Movement, Condorcet, Tournai, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation	we will observe effect of adjunction of a DTM on PaO2	30 minutes
Secondary	PaCO2	we will observe the effect of the addition of the DTM on PaCO2	30 minutes