Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2018-11-20

Brief Summary

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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.

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Detailed Description

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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

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Hypoxia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Comparison of level oxygenation between classical oxygenation with nasal canulae with or without adjunctive of a double trunk mask

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double Trunk Mask

DTM will be add above nasal cannula

Group Type EXPERIMENTAL

DTM will be add above NC

Intervention Type DEVICE

After oxygenation by classical nasal cannula, the DTM will be place above NC

Nasal Cannula Alone

Patients receive oxygen only thought nasal Cannula

Group Type ACTIVE_COMPARATOR

DTM will be add above NC

Intervention Type DEVICE

After oxygenation by classical nasal cannula, the DTM will be place above NC

Interventions

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DTM will be add above NC

After oxygenation by classical nasal cannula, the DTM will be place above NC

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No