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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified

Treatments

Device: Non-invasive mechanical ventilation - Controlled hypoxemia
Device: Non-invasive mechanical ventilation - Normoxia

Study type

Interventional

Funder types

Other

Identifiers

NCT02563314
ANSM (Other Identifier)
1408025

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1 participants in 2 patient groups

intervention
Experimental group
Treatment:
Device: Non-invasive mechanical ventilation - Normoxia
control
Other group
Treatment:
Device: Non-invasive mechanical ventilation - Controlled hypoxemia

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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