Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen supply and better oxygen control than manually controlled oxygen therapy for patients admitted to the emergency department with acute hypoxemia. Furthermore it will be tested if O2matic compared to manual control allows for earlier discharge.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

NCT04565106

Covid19 Hypoxemic Respiratory Failure Hypoxemia

COMPLETED

Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

NCT06374225

Critical Illness Wounds and Injury Disease Attributes +1 more

ACTIVE_NOT_RECRUITING NA

NeO2Matic-Pilot Trial

NCT05629910

Pre-Term Respiratory Distress Syndrome, Newborn Retinopathy of Prematurity +1 more

NOT_YET_RECRUITING NA

Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation

NCT01513655

Chronic Obstructive Pulmonary Disease Acute Exacerbation of Chronic Obstructive Airways Disease Chronic Hypercapnic Respiratory Failure

UNKNOWN PHASE4

The Effect of Oxygen Therapy With Airvo High-flow Heated Humidification

NCT02731872

COPD

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Closed-loop control of oxygen therapy is described in the literature used for preterm infants, trauma patients, medical emergency use, and for patients with Chronic Obstructive Pulmonary Disease (COPD). O2matic is a closed-loop system that is based on continuous and non-invasive measurement of pulse rate and oxygen-saturation (SpO2). The algorithm in O2matic controls oxygen delivery with the aim of keeping the SpO2 within the desired interval, which could be 88-92 % for patients at risk of hypercapnia or 94-98 % for patients with pneumonia, asthma exacerbation, heart failure and other medical emergencies, according to guidelines from British Thoracic Society (BTS). SpO2-interval can be set for the individual patients, as can the range of acceptable oxygen-flow. If SpO2 or oxygen-flow cannot be maintained within the desired intervals an alarm will sound.

All studies on closed-loop systems have shown that this method is better than manually control by nurse to maintain saturation within the desired interval. Furthermore, some studies have indicated that closed-loop has the possibility to reduce admission time and to reduce time spent with oxygen therapy, due to more efficient and faster withdrawal from oxygen supplementation.

In the present study O2matic will be tested versus manual control, for patients admitted to the emergency department with acute hypoxemia due to any reason, except for carbon monoxide (CO) poisoning and other conditions where SpO2 is not a reliable measure of hypoxemia. During the study the patients will either have oxygen controlled with O2matic or manually by nursing staff for 24 hours or until discharge or weaning from oxygen supply. All patients will have continuous logging of pulse rate, oxygen-saturation and oxygen-flow with O2matic, but only in the O2matic active group, the algorithm will control oxygen-delivery.

The primary hypothesis is that O2matic compared to manual control allows for faster weaning from oxygen supplementation, and that more patients will be weaned from oxygen supplementation within a time frame of 24 hours. Furthermore it will be tested if O2matic compared to manual control allows for earlier hospital discharge. It will be tested if O2matic is better than manual control in maintaining oxygen-saturation within the desired interval and reducing time with unintended hypoxia and hyperoxia.

No safety issues has been reported in the literature. O2matic is approved in Europe with "Conformité Européenne" (CE) mark, and approved for clinical testing by The Danish Medicines Agency, The Ethics Committee in the Capital Region of Denmark and by the regional Data Protection Board. The study will be conducted according to Good Clinical Practice (GCP) standards with independent monitoring. All adverse events and serious adverse events will be monitored and serious adverse events will be reported to Danish Medicines Agency.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxemic Respiratory Failure Hypoxia Hypoxemia Respiratory Failure Respiratory Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open label randomized controlled parallel study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

O2matic

Usual care plus O2matic controlled oxygen therapy for a maximum of 24 hours or until weaning from oxygen supplementation

Group Type ACTIVE_COMPARATOR

O2matic

Intervention Type DEVICE

O2matic controls oxygen supply with a closed-loop feedback from a pulse oximeter. The aim is to maintain SpO2 within a predefined target interval according to guidelines for the specific condition causing hypoxemia, with the lowest possible supplementation of oxygen.

Manual

Usual care plus manual controlled oxygen therapy by nursing staff. O2matic is used in monitoring mode to measure SpO2 continuously.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

O2matic

O2matic controls oxygen supply with a closed-loop feedback from a pulse oximeter. The aim is to maintain SpO2 within a predefined target interval according to guidelines for the specific condition causing hypoxemia, with the lowest possible supplementation of oxygen.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Admission with hypoxemic respiratory failure
* Age \>= 18 years
* Expected duration of admission \> 24 hours
* Need for oxygen supplementation to maintain SpO2 \>= 88 % (patients at risk of hypercapnia) or SpO2 \>= 94 % (other patients)
* Cognitively able to participate in the study
* Willing to participate and give informed consent

Exclusion Criteria

* Need or anticipated need for mechanical ventilation (intermittent Continuous Positive Airway Pressure (CPAP) is allowed)
* Patients with CO-poisoning or other condition with unreliable SpO2.
* Patients in need of oxygen supplementation at more than 10 liters/min
* Pregnancy
* Cognitive or language barriers for participation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No