Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

Laboratory of Movement, Condorcet, Tournai, Belgium

Status: Completed

Conditions: Hypoxia

Treatments: Device: DTM will be add above NC

Study type: Interventional

Funder types: Other

Identifiers

NCT03457363

Duprezbruyneel

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

Double Trunk Mask

Experimental group

Description:

DTM will be add above nasal cannula

Treatment:

Device: DTM will be add above NC

Nasal Cannula Alone

Active Comparator group

Description:

Patients receive oxygen only thought nasal Cannula

Treatment:

Device: DTM will be add above NC