Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19

• ClinicalTrials.gov Identifier: NCT04346420
• Recruitment Status: Completed
• First Posted: April 15, 2020
• Last Update Posted: June 9, 2020
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Information provided by (Responsible Party): Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 15, 2020
• Last Update Posted Date: June 9, 2020
• Actual Study Start Date: April 9, 2020
• Actual Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2020)

Change in O2 output [ Time Frame: At baseline and 30 minutes after wearing both systems ]

The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 13, 2020)

• Comfort with the interfaces [ Time Frame: 30 minutes after wearing both systems ]
  A Likert scale from 0 to 5 will be used to measure the subjective comfort of the patient while wearing the standard interface for administering O2 and/or the DTM
• Changes in PaO2 [ Time Frame: At baseline and 30 minutes after wearing DTM ]
  Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
• Changes in PaCO2 [ Time Frame: At baseline and 30 minutes after wearing DTM ]
  Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.
• Changes in pH [ Time Frame: At baseline and 30 minutes after wearing DTM ]
  Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
• Changes in respiratory rate [ Time Frame: At baseline and 30 minutes after wearing both systems ]
  Respiratory rate is measured during one minute by visual inspection.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19
• Official Title: Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19
• Brief Summary: This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.

Detailed Description

The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.

Each included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• COVID
• Hypoxemia

Intervention

• Other: Standard interface
  The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.
• Device: Double-Trunk Mask
  The standard nasal cannula interface accompanied with the DTM is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.

Study Arms

• Experimental: O2 DTM+
  The standard nasal cannula interface is accompanied with the DTM
  Intervention: Device: Double-Trunk Mask
• Active Comparator: O2 DTM-
  The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM
  Intervention: Other: Standard interface

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2020): 12
• Original Estimated Enrollment (submitted: April 13, 2020): 15
• Actual Study Completion Date: May 1, 2020
• Actual Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• COVID-19
• SpO2 between 92 and 96% with low-flow oxygen therapy (< 15 L/min).

Exclusion Criteria:

• Chronic obstructive pulmonary disease or other chronic respiratory disease
• Confusion
• Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min
• Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT04346420
• Other Study ID Numbers: DTM-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Study Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Verification Date: June 2020