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Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19

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ClinicalTrials.gov Identifier: NCT04629989
Recruitment Status : Completed
First Posted : November 16, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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).

Condition or disease Intervention/treatment Phase
Covid19 Hypoxemia Other: Standard Oxygen Delivery System Other: Double-Trunk Mask Other: Surgical Mask Not Applicable

Detailed Description:
Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask
Actual Study Start Date : November 13, 2020
Actual Primary Completion Date : March 5, 2021
Actual Study Completion Date : March 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Low-flow nasal cannula
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
The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

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

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




Primary Outcome Measures :
  1. Changes in PaO2 [ Time Frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system ]
    Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system


Secondary Outcome Measures :
  1. Change in PaCO2 [ Time Frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system ]
    Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.

  2. Change in pH [ Time Frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system ]
    Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.

  3. Change in respiratory rate [ Time Frame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system ]
    Respiratory rate is measured during one minute by visual inspection.

  4. Change in dyspnea [ Time Frame: At baseline and 60 minutes after wearing the randomized oxygen delivery system ]
    Dyspnea is rated with a visual analogic scale (0 to 100mm).

  5. Change in O2 output [ Time Frame: At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system ]
    The O2 output will be adjusted to recover the baseline SpO2 reading. The O2 output will be read from the position of the ball inside the flowmeter.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pulmonary disease with hypercapnia
  • Confusion
  • Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629989


Locations
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Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Responsible Party: Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04629989    
Other Study ID Numbers: DTM-003
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Double-Trunk Mask
Surgical Mask
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory