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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346420
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE April 9, 2020
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • COVID
  • Hypoxemia
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2020)
15
Actual Study Completion Date  ICMJE May 1, 2020
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04346420
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP