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

Effect of a Double Trunk Mask Associated to Nasal Prongs During a High Flow Oxygenation Method

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.

Study Overview

• Status: Completed
• Conditions: Oxygen Inhalation Therapy
• Intervention / Treatment: Device: Double trunk mask add above a nasal canulae

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hainaut
    • Hornu, Hainaut, Belgium, 7301
      • Epicura Hornu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Patients were excluded if they Hypercapnia (> 45 mm Hg with respiratory acidosis), cardiogenic pulmonary edema, COPD, pulmonary fibrosis, hypoventilation obesity syndrom, 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 (CHFONP) classical High Flow Oxygenation with nasal prongs (20 minutes) or CHFNOP with an adjunctive of a DTM.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oxygenation only with nasal canula; intervention: classical oxygenation with nasal canula (High flow)	Device: Double trunk mask add above a nasal canulae; oxygenation only with nostril prongs
EXPERIMENTAL: Oxygenation with double trunk masknasal canula; oxygenationwith DTM above nasal canula	Device: Double trunk mask add above a nasal canulae; oxygenation only with nostril prongs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of blood oxygenation (PaO2) after adjunction of a double trunk mask to a high flow oxygen canulae	The primary endpoint was the change of PaO2. Sequence (Figure 1): The patient should be placed in semi-seated (position at 45 °) Patient will be oxygenated with high-fow nasal cannula (HFNC). Fraction delivered in Oxygen and flow rate will be adjusted to obtain a Saturation in oxygen > at 90%.; Arterial gazometry will be taken after 20 and 60 minutes wih HFNC.; The clinician will associate the Double Trunk Mask (DTM) with the same parameters of the high-fow nasal cannula. Arterial gazometry will be performed after 20 and 60 minutes after placement of DTM.; After the withdrawal of DTM, arterial gazometry will be performed after 20 and 60 minutes	4 hours

Collaborators and Investigators

• Sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium
• Investigators: Principal Investigator: frédéric mr duprez, Msc, Condorcet

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): September 2, 2017

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (ACTUAL): October 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: acute respiratory failure; oxygen mask; high-flow oxygen therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: HFODTM01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No