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

Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified Clinical Trial

— OXYSET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02563314
• Other study ID #: 1408025
• Secondary ID: ANSM
• Status: Terminated
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: September 24, 2018

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 24, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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

Locations

Country	Name	City	State
France	CHU de CLERMONT-FERRAND	Clermont-ferrand
France	CHu de GRENOBLE	Grenoble
France	CHU de la Pitié-Salpêtrière	Paris
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary output (ml)	First 24 hours of non-invasive mechanical ventilation	24 hours
Secondary	Changes in CO2 levels	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	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
Secondary	Serum creatinine	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	Renal resistive index	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	Pulmonary arterial pressure	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	Semiquantitative assessment of dyspnea (visual likert scale)	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	Semiquantitative assessment of comfort (visual likert scale)	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	Fluid balance	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	SOFA (Sequential Organ Failure Assessment) score	First 24 hours of non-invasive mechanical ventilation	24 hours, 48 hours, 72hours
Secondary	Mortality	First 24 hours of non-invasive mechanical ventilation	up to day 28
Secondary	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
Secondary	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