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

NCT03319602 | Completed DMC

• 1 other identifier: HFODTM01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Inhalation Therapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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%. 1. Arterial gazometry will be taken after 20 and 60 minutes wih HFNC. 2. 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. 3. After the withdrawal of DTM, arterial gazometry will be performed after 20 and 60 minutes

  4 hours

Study Arms (2)

Oxygenation only with nasal canula

ACTIVE COMPARATOR

intervention: classical oxygenation with nasal canula (High flow)

Device: Double trunk mask add above a nasal canulae

Oxygenation with double trunk masknasal canula

EXPERIMENTAL

oxygenationwith DTM above nasal canula

Device: Double trunk mask add above a nasal canulae

Interventions

Double trunk mask add above a nasal canulae DEVICE

oxygenation only with nostril prongs

Oxygenation only with nasal canula; Oxygenation with double trunk masknasal canula

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

epicura Hornu

Hornu, Hainaut, 7301, Belgium

Location

Related Publications (2)

• 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.

  PMID: 9635651 RESULT

• 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.

  PMID: 1959399 RESULT

Study Officials

• frédéric mr duprez, Msc

  Condorcet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research collaborator

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: October 5, 2017
• First Posted: October 24, 2017
• Study Start: February 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: September 2, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)