NCT04383821

Brief Summary

This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of patients with severe hypoxemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

May 7, 2020

Last Update Submit

February 6, 2022

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

  • Changes in PaO2

    Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

    At baseline and 30 minutes after wearing DTM

Secondary Outcomes (5)

  • Changes in PaCO2

    At baseline and 30 minutes after wearing DTM

  • Changes in pH

    At baseline and 30 minutes after wearing DTM

  • Changes in respiratory rate

    At baseline and 30 minutes after wearing both systems

  • Comfort with the oxygen delivery systems

    30 minutes after wearing both systems

  • Dyspnea with the oxygen delivery systems

    30 minutes after wearing both systems

Study Arms (2)

Double-Trunk Mask

EXPERIMENTAL

The oxygen delivery system is the DTM

Device: Double-Trunk Mask

Non-Rebreather Mask

ACTIVE COMPARATOR

The oxygen delivery system is the NRM

Device: Non-Rebreather mask

Interventions

Double-Trunk MaskDEVICE

The DTM (oxygen delivery system) is worn by the patient for 30 minutes.

Double-Trunk Mask
Non-Rebreather maskDEVICE

The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.

Non-Rebreather Mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute hypoxemia not corrected with nasal cannula

You may not qualify if:

  • Chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia
  • Confusion
  • Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Epicura

Hornu, Belgium

Location

Centre Hospitalier Universitaire de Tivoli

La Louvière, Belgium

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

May 15, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

BE(3)