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Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD

NCT03464695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-01-08

No results posted yet for this study

Summary

The aim of the study is to examine if automated oxygen delivery with O2matic is better than manually controlled oxygen therapy for patients admitted to hospital with an exacerbation in Chronic Obstructive Pulmonary Disease (COPD).

O2matic is a closed -loop system based on continuous non-invasive measurement of pulse and oxygen-saturation that is processed in an algorithm that controls the flow of oxygen to the patient.

The primary hypothesis is that O2matic increases time within acceptable oxygen-saturation interval. Secondary hypotheses are that O2matic compared to manual control reduces time with severe hypoxia (SpO2 \< 85 %), hypoxi (SpO2 below intended interval) and hyperoxia (SpO2 above intended interval).

Conditions

Interventions

DEVICE

O2matic

Continous measurement of SpO2 during an admission with COPD, and closed-loop control of oxygen-delivery to maintain SpO2 within a target interval.

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Jørgen Vestbo, DMSc · Manchester University Hospital

  • Ejvind Frausing Hansen, MD · Hvidovre University Hospital, Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2018-08-08
Completion
2018-08-08

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03464695 on ClinicalTrials.gov