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

Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
• Intervention / Treatment: Device: Non-invasive mechanical ventilation - Normoxia; Device: Non-invasive mechanical ventilation - Controlled hypoxemia

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Grenoble, France, 38000
    • Chu de Grenoble
  • Paris, France, 75013
    • Chu De La Pitie-Salpetriere
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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%)
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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary output (ml)	First 24 hours of non-invasive mechanical ventilation	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in CO2 levels	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
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	24 hours, 48 hours, 72 hours
Serum creatinine	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Renal resistive index	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Pulmonary arterial pressure	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Semiquantitative assessment of dyspnea (visual likert scale)	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Semiquantitative assessment of comfort (visual likert scale)	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Fluid balance	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
SOFA (Sequential Organ Failure Assessment) score	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Mortality	First 24 hours of non-invasive mechanical ventilation	up to day 28
Number of patients requiring mechanical ventilation	Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge	up to day 28
days alive without mechanical ventilation	Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge	up to day 28

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): September 24, 2018
• Study Completion (Actual): September 24, 2018

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Noninvasive Ventilation; Hypercapnia; Oxygen; Pulmonary Disease; Chronic Obstructive; Renal Doppler
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1408025; ANSM (Other Identifier: 2025-A01697-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No