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

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified Device: Non-invasive mechanical ventilation - Normoxia Device: Non-invasive mechanical ventilation - Controlled hypoxemia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Actual Study Start Date : March 22, 2017
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : September 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention Device: Non-invasive mechanical ventilation - Normoxia
Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)

control Device: Non-invasive mechanical ventilation - Controlled hypoxemia
Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)




Primary Outcome Measures :
  1. urinary output (ml) [ Time Frame: 24 hours ]
    First 24 hours of non-invasive mechanical ventilation


Secondary Outcome Measures :
  1. Changes in CO2 levels [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  2. 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

  3. Serum creatinine [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  4. Renal resistive index [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  5. Pulmonary arterial pressure [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  6. Semiquantitative assessment of dyspnea (visual likert scale) [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  7. Semiquantitative assessment of comfort (visual likert scale) [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  8. Fluid balance [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  9. SOFA (Sequential Organ Failure Assessment) score [ Time Frame: 24 hours, 48 hours, 72hours ]
    First 24 hours of non-invasive mechanical ventilation

  10. Mortality [ Time Frame: up to day 28 ]
    First 24 hours of non-invasive mechanical ventilation

  11. 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

  12. 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



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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:

  • 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

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): NCT02563314


Locations
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France
CHU de CLERMONT-FERRAND
Clermont-ferrand, France, 63000
CHu de GRENOBLE
Grenoble, France, 38000
CHU de la Pitié-Salpêtrière
Paris, France, 75013
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Michael DARMON, MD PhD CHU de SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02563314     History of Changes
Other Study ID Numbers: 1408025
ANSM ( Other Identifier: 2014-A00319-38 )
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Centre Hospitalier Universitaire de Saint Etienne:
Noninvasive Ventilation
Pulmonary Disease
Chronic Obstructive
Renal Doppler
Oxygen
Hypercapnia
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases