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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Covid19; Hypoxemia

Treatments: Other: Standard Oxygen Delivery System; Other: Double-Trunk Mask; Other: Surgical Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04629989

DTM-003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

27 participants in 3 patient groups

Low-flow nasal cannula

Active Comparator group

Description:

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

Treatment:

Other: Standard Oxygen Delivery System

Double-Trunk Mask

Experimental group

Description:

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

Treatment:

Other: Double-Trunk Mask

Surgical Mask

Experimental group

Description:

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

Treatment:

Other: Surgical Mask