Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

NCT03457363 | Completed

• 1 other identifier: Duprezbruyneel
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

oxygen; nasal cannula; double trunk mask; hypoxia

Outcome Measures

Primary Outcomes (1)

• Oxygenation

  we will observe effect of adjunction of a DTM on PaO2

  30 minutes

Secondary Outcomes (1)

• PaCO2

  30 minutes

Study Arms (2)

Double Trunk Mask

EXPERIMENTAL

DTM will be add above nasal cannula

Device: DTM will be add above NC

Nasal Cannula Alone

ACTIVE COMPARATOR

Patients receive oxygen only thought nasal Cannula

Device: DTM will be add above NC

Interventions

DTM will be add above NC DEVICE

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

Double Trunk Mask; Nasal Cannula Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratory of Movement, Condorcet, Tournai, Belgium: lead

Study Sites (1)

Epicura

Hornu, Hainaut, 7301, Belgium

Location

Related 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.

  PMID: 26566938 BACKGROUND

• 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.

  PMID: 15871753 BACKGROUND

• 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. doi: 10.1164/arrd.1984.130.3.500.

  PMID: 6476597 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EPICURA ICU Hornu

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

Study Record Dates

• First Submitted: February 24, 2018
• First Posted: March 7, 2018
• Study Start: June 20, 2018
• Primary Completion: July 20, 2018
• Study Completion: November 20, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)