Effect of a Modified Oxygen Mask Associated to Nasal Prongs During a High Flow Oxygenation Method

NCT ID: NCT03319602

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-09-02

Brief Summary

The aim of this study is to determine the effect (on PaO2) of a modified mask associated to nasal cannula used for high flow oxygenation.

Detailed Description

Study Design This is a single-center, randomized, blind investigator, 2-way crossover study design. Enrolled participants had severe hypoxia being treated at Intensive Care Unit associated with a hospital in Hornu (Epicura).

The study consisted of two intervention periods of 2 weeks separated by a washout period of 20 minutes. (Figure 1) 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.

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.

Statistical Analysis

All participants who received this intervention and completed two phases of study were included in the efficacy analysis.

A sample size of 15 participants was needed to provide 90% power to detect a 10 mm Hg difference in PaO2. ANOVA for repeated measures followed by a post hoc test were used to compare the difference between participants receiving (CHFONP + DTM) and CHFONP alone.

The test was performed with a significance level of 0.05 (two-sided). Statistical analyses were carried out using SigmaPlot software version 11.0 (Systat Software Inc. UK).

Adverse Event Assessment

Safety was assessed by the number of participants with adverse events (AEs). AEs were collected by systematic assessment using terms from the Medical Dictionary for Regulatory Activities (MedDRA), version 11.1 in participants who received one or more doses of intervention. Adverse events during washout were not collected.

Conditions

Oxygen Inhalation Therapy

Keywords

oxygen mask; high-flow oxygen therapy; acute respiratory failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oxygenation only with nasal canula

intervention: classical oxygenation with nasal canula (High flow)

Group Type: ACTIVE_COMPARATOR

Double trunk mask add above a nasal canulae

Intervention Type: DEVICE

oxygenation only with nostril prongs

Oxygenation with double trunk masknasal canula

oxygenationwith DTM above nasal canula

Group Type: EXPERIMENTAL

Double trunk mask add above a nasal canulae

Intervention Type: DEVICE

oxygenation only with nostril prongs

Interventions

Double trunk mask add above a nasal canulae

oxygenation only with nostril prongs

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Regardless of gender, at least 18 years of age and diagnosed with severe Hypoxia (PaO2/FiO2 < 300 mm Hg), dyspnea with severe rest at stake accessory muscles of respiration, 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

Participants were randomized in a 1:1 ratio to receive either (CHFONP) classical High Flow Oxygenation with nasal prongs (20 minutes) or CHFNOP with an adjunctive of a DTM.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratory of Movement, Condorcet, Tournai, Belgium

OTHER

Sponsor Role: lead

Responsible Party

frédéric Duprez

Research collaborator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

frédéric mr duprez, Msc

Role: PRINCIPAL_INVESTIGATOR

Condorcet

Locations

epicura Hornu

Hornu, Hainaut, Belgium

Countries

Belgium

References

Hnatiuk OW, Moores LK, Thompson JC, Jones MD. Delivery of high concentrations of inspired oxygen via Tusk mask. Crit Care Med. 1998 Jun;26(6):1032-5. doi: 10.1097/00003246-199806000-00022.

Reference Type: RESULT

PMID: 9635651 (View on PubMed)

Chechani V, Scott G, Burnham B, Knight L. Modification of an aerosol mask to provide high concentrations of oxygen in the inspired air. Comparison to a nonrebreathing mask. Chest. 1991 Dec;100(6):1582-5. doi: 10.1378/chest.100.6.1582.

Reference Type: RESULT

PMID: 1959399 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HFODTM01

Identifier Type: -

Identifier Source: org_study_id