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Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

Primary Purpose

Hypoxia

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

DTM will be add above NC

About this trial

This is an interventional treatment trial for Hypoxia focused on measuring oxygen, nasal cannula, double trunk mask, hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Epicura

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Double Trunk Mask

Nasal Cannula Alone

Arm Description

DTM will be add above nasal cannula

Patients receive oxygen only thought nasal Cannula

Outcomes

Primary Outcome Measures

Oxygenation

we will observe effect of adjunction of a DTM on PaO2

Secondary Outcome Measures

PaCO2

we will observe the effect of the addition of the DTM on PaCO2

Full Information

NCT ID

NCT03457363

First Posted

February 24, 2018

Last Updated

July 22, 2019

Sponsor

Laboratory of Movement, Condorcet, Tournai, Belgium

1. Study Identification

Unique Protocol Identification Number

NCT03457363

Brief Title

Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

June 20, 2018 (Actual)

Primary Completion Date

July 20, 2018 (Actual)

Study Completion Date

November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laboratory of Movement, Condorcet, Tournai, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxia

Keywords

oxygen, nasal cannula, double trunk mask, hypoxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Double Trunk Mask

Arm Type

Experimental

Arm Description

DTM will be add above nasal cannula

Arm Title

Nasal Cannula Alone

Arm Type

Active Comparator

Arm Description

Patients receive oxygen only thought nasal Cannula

Intervention Type

Device

Intervention Name(s)

DTM will be add above NC

Intervention Description

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

Primary Outcome Measure Information:

Title

Oxygenation

Description

we will observe effect of adjunction of a DTM on PaO2

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

PaCO2

Description

we will observe the effect of the addition of the DTM on PaCO2

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Epicura

City

Hornu

State/Province

Hainaut

ZIP/Postal Code

7301

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26566938

Citation

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.

Results Reference

background

PubMed Identifier

15871753

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.

Results Reference

background

PubMed Identifier

6476597

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. doi: 10.1164/arrd.1984.130.3.500.

Results Reference

background

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Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

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