NCT04629989

Brief Summary

This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

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

November 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

November 13, 2020

Last Update Submit

March 8, 2021

Conditions

Covid19Hypoxemia

Keywords

Double-Trunk MaskSurgical Mask

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 the randomized oxygen delivery system

Secondary Outcomes (5)

  • Change in PaCO2

    At baseline and 30 minutes after wearing the randomized oxygen delivery system

  • Change in pH

    At baseline and 30 minutes after wearing the randomized oxygen delivery system

  • Change in respiratory rate

    At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system

  • Change in dyspnea

    At baseline and 60 minutes after wearing the randomized oxygen delivery system

  • Change in O2 output

    At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system

Study Arms (3)

Low-flow nasal cannula

ACTIVE COMPARATOR

The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM

Other: Standard Oxygen Delivery System

Double-Trunk Mask

EXPERIMENTAL

The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).

Other: Double-Trunk Mask

Surgical Mask

EXPERIMENTAL

The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).

Other: Surgical Mask

Interventions

Standard Oxygen Delivery SystemOTHER

The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Low-flow nasal cannula
Double-Trunk MaskOTHER

The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Double-Trunk Mask
Surgical MaskOTHER

The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Surgical Mask

Eligibility Criteria

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

You may qualify if:

  • COVID-19 positive
  • SpO2 between 92 and 96% with low-flow oxygen therapy
  • Oxygen output at baseline between 3 and 7 L/min.

You may not qualify if:

  • Pulmonary 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 (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

COVID-19Hypoxia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 16, 2020

Study Start

November 13, 2020

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

BE(1)