O2matic Cardiology Protocol

Not Applicable

Recruiting

• Conditions: Heart Diseases
• Interventions: Device: Manual oxygen supply and adjustments; Device: O2matic administered oxygen

• Registration Number: NCT05452863
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Automatic oxygen supply with the O2matic device has been shown to provided an enhanced oxygen treatment in patients with hypoxemia. O2matic was significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia in patients suffering from chronic obstructive pulmonary disease. This trial investigates the effect of using O2matic in hypoxic patients submitted to the Department of Cardiology.

Detailed Description

Oxygen supply to patients with cardiovascular disease has been subject to several investigations. Both too much and too little oxygen is supposed to be harmful. The O2matic device is a new way of supplying oxygen treatment which is significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia. The device has past favorable tests in patients suffering from chronic obstructive pulmonary disease. This study investigates the application of the O2matic device on hypoxic patients admitted to the Cardiology ward.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with heart disease and an oxygen saturation below 94% admitted to the Department of Cardiology
• Age of 30 or more
• Intellectual capacity to participate in the trial
• Willing to give informed accept of participation in the trial.

Exclusion Criteria

• Unstable patients
• Need for ventilatory support except intermittent continuous positive airway pressure
• Fertile women (age<55 years) with a positive pregnancy test
• Unable to participate due to language or cognitive problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual oxygen supply	Manual oxygen supply and adjustments	Oxygen will be supplied by nurse adjustments in the usual way
Automatic oxygen supply	O2matic administered oxygen	Oxygen will be supplied by the O2matic device

Primary Outcome Measures

Name	Time	Method
Time in designated saturation interval	24 hours of treatment	We have predefined an optimum saturation interval of 92-96% with a target of 93%

Secondary Outcome Measures

Name	Time	Method
Time with hypoxemia	24 hours of treatment	Time with saturation below 92% but above 85%
Time with hyperoxemia	24 hours of treatment	Time with saturation above 96%
Time with severe hypoxemia	24 hours of treatment	Time with saturation below 85%

Trial Locations

Locations (1)

Amager and Hvidovre Hospital University of Copenhagen; 🇩🇰 Copenhagen, Denmark