NCT02563314

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2018

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

September 24, 2015

Last Update Submit

June 12, 2019

Conditions

Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified

Keywords

Noninvasive VentilationPulmonary DiseaseChronic ObstructiveRenal DopplerOxygenHypercapnia

Outcome Measures

Primary Outcomes (1)

  • urinary output (ml)

    First 24 hours of non-invasive mechanical ventilation

    24 hours

Secondary Outcomes (12)

  • Changes in CO2 levels

    24 hours, 48 hours, 72hours

  • respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration)

    24 hours, 48 hours, 72 hours

  • Serum creatinine

    24 hours, 48 hours, 72hours

  • Renal resistive index

    24 hours, 48 hours, 72hours

  • Pulmonary arterial pressure

    24 hours, 48 hours, 72hours

  • +7 more secondary outcomes

Study Arms (2)

intervention

EXPERIMENTAL
Device: Non-invasive mechanical ventilation - Normoxia

control

OTHER
Device: Non-invasive mechanical ventilation - Controlled hypoxemia

Interventions

Non-invasive mechanical ventilation - NormoxiaDEVICE

Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)

intervention
Non-invasive mechanical ventilation - Controlled hypoxemiaDEVICE

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

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU de CLERMONT-FERRAND

Clermont-Ferrand, 63000, France

Location

CHu de GRENOBLE

Grenoble, 38000, France

Location

CHU de la Pitié-Salpêtrière

Paris, 75013, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Lung DiseasesHypercapnia

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael DARMON, MD PhD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 30, 2015

Study Start

March 22, 2017

Primary Completion

September 24, 2018

Study Completion

September 24, 2018

Last Updated

June 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)