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

Primary Purpose

Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non-invasive mechanical ventilation - Normoxia
Non-invasive mechanical ventilation - Controlled hypoxemia
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified focused on measuring Noninvasive Ventilation, Pulmonary Disease, Chronic Obstructive, Renal Doppler, Oxygen, Hypercapnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de CLERMONT-FERRAND
  • CHu de GRENOBLE
  • CHU de la Pitié-Salpêtrière
  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

intervention

control

Arm Description

Outcomes

Primary Outcome Measures

urinary output (ml)
First 24 hours of non-invasive mechanical ventilation

Secondary Outcome Measures

Changes in CO2 levels
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)
First 24 hours of non-invasive mechanical ventilation
Serum creatinine
First 24 hours of non-invasive mechanical ventilation
Renal resistive index
First 24 hours of non-invasive mechanical ventilation
Pulmonary arterial pressure
First 24 hours of non-invasive mechanical ventilation
Semiquantitative assessment of dyspnea (visual likert scale)
First 24 hours of non-invasive mechanical ventilation
Semiquantitative assessment of comfort (visual likert scale)
First 24 hours of non-invasive mechanical ventilation
Fluid balance
First 24 hours of non-invasive mechanical ventilation
SOFA (Sequential Organ Failure Assessment) score
First 24 hours of non-invasive mechanical ventilation
Mortality
First 24 hours of non-invasive mechanical ventilation
Number of patients requiring mechanical ventilation
Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
days alive without mechanical ventilation
Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge

Full Information

First Posted
September 24, 2015
Last Updated
June 12, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02563314
Brief Title
Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease
Acronym
OXYSET
Official Title
Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
departure of the coordinating investigator from another institution
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
Keywords
Noninvasive Ventilation, Pulmonary Disease, Chronic Obstructive, Renal Doppler, Oxygen, Hypercapnia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Title
control
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Non-invasive mechanical ventilation - Normoxia
Intervention Description
Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)
Intervention Type
Device
Intervention Name(s)
Non-invasive mechanical ventilation - Controlled hypoxemia
Intervention Description
Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)
Primary Outcome Measure Information:
Title
urinary output (ml)
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Changes in CO2 levels
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration)
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72 hours
Title
Serum creatinine
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
Renal resistive index
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
Pulmonary arterial pressure
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
Semiquantitative assessment of dyspnea (visual likert scale)
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
Semiquantitative assessment of comfort (visual likert scale)
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
Fluid balance
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
SOFA (Sequential Organ Failure Assessment) score
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
24 hours, 48 hours, 72hours
Title
Mortality
Description
First 24 hours of non-invasive mechanical ventilation
Time Frame
up to day 28
Title
Number of patients requiring mechanical ventilation
Description
Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
Time Frame
up to day 28
Title
days alive without mechanical ventilation
Description
Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
Time Frame
up to day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael DARMON, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de CLERMONT-FERRAND
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHu de GRENOBLE
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CHU de la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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