Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease (OXYSET)

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: NCT02563314
Recruitment Status : Terminated (departure of the coordinating investigator from another institution)
First Posted : September 30, 2015
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE March 22, 2017
Actual Primary Completion Date September 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
urinary output (ml) [ Time Frame: 24 hours ]
First 24 hours of non-invasive mechanical ventilation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
  • Changes in CO2 levels [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration) [ Time Frame: 24 hours, 48 hours, 72 hours ]
    First 24 hours of non-invasive mechanical ventilation
  • Serum creatinine [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • Renal resistive index [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • Pulmonary arterial pressure [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • Semiquantitative assessment of dyspnea (visual likert scale) [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • Semiquantitative assessment of comfort (visual likert scale) [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • Fluid balance [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • SOFA (Sequential Organ Failure Assessment) score [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation
  • Mortality [ Time Frame: up to day 28 ]
    First 24 hours of non-invasive mechanical ventilation
  • Number of patients requiring mechanical ventilation [ Time Frame: up to day 28 ]
    Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
  • days alive without mechanical ventilation [ Time Frame: up to day 28 ]
    Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Changes in CO2 levels [ Time Frame: 24 hours, 48 hours, 72hours ]
  • respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration) [ Time Frame: 24 hours, 48 hours, 72 hours ]
  • Serum creatinine [ Time Frame: 24 hours, 48 hours, 72hours ]
  • Renal resistive index [ Time Frame: 24 hours, 48 hours, 72hours ]
  • Pulmonary arterial pressure [ Time Frame: 24 hours, 48 hours, 72hours ]
  • Semiquantitative assessment of dyspnea (visual likert scale) [ Time Frame: 24 hours, 48 hours, 72hours ]
  • Semiquantitative assessment of comfort (visual likert scale) [ Time Frame: 24 hours, 48 hours, 72hours ]
  • Fluid balance [ Time Frame: 24 hours, 48 hours, 72hours ]
  • SOFA (Sequential Organ Failure Assessment) score [ Time Frame: 24 hours, 48 hours, 72hours ]
  • Mortality [ Time Frame: up to day 28 ]
  • Number of patients requiring mechanical ventilation [ Time Frame: up to day 28 ]
    Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
  • days alive without mechanical ventilation [ Time Frame: up to day 28 ]
    Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease
Official Title  ICMJE Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Brief Summary Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
Intervention  ICMJE
  • Device: Non-invasive mechanical ventilation - Normoxia
    Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)
  • Device: Non-invasive mechanical ventilation - Controlled hypoxemia
    Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)
Study Arms  ICMJE
  • Experimental: intervention
    Intervention: Device: Non-invasive mechanical ventilation - Normoxia
  • control
    Intervention: Device: Non-invasive mechanical ventilation - Controlled hypoxemia
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2015)
88
Actual Study Completion Date  ICMJE September 24, 2018
Actual Primary Completion Date September 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years
  • Acute hypercapnic COPD exacerbation
  • Respiratory acidosis
  • Intensive care unit admission
  • Non-Invasive mechanical ventilation for less than 24 hours
  • Patients or proxy consent
  • Patients affiliated with the General Social Security Health System

Exclusion Criteria:

  • Pregnancy
  • Sickle cells disease
  • Acute coronary syndrome
  • Restrictive respiratory disease
  • Stage 4 or 5 chronic kidney disease
  • COPD exacerbation following a first episode of conventional mechanical ventilation
  • Contraindications to non-invasive ventilation
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563314
Other Study ID Numbers  ICMJE 1408025
ANSM ( Other Identifier: 2014-A00319-38 )
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael DARMON, MD PhD CHU de SAINT-ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date June 2019

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