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Behavioural Intervention

Automated Oxygen Titration for Critical Illness (SAVE-O2 AI Trial)

N/A

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized or will be hospitalized from Emergency Department for major trauma, burn, acute care surgery, or acute respiratory illness

Receiving supplemental oxygen 1-10 liters per minute for documented or presumed hypoxemia (must be higher than baseline for those on chronic oxygen therapy)

Must not have

Imminent plans to administer high flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation

Known contraindicated conditions for use of the PRO100 device: carbon monoxide poisoning, incapable of handling airway secretions, increased methemoglobin, cyanide poisoning, cluster headaches, undrained pneumothorax, sickle cell crisis, paraquat poisoning or a history of bleomycin poisoning, patients for whom the SpO2 signal is not stable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up censored at day 28, discharge if before day 28, or death.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new system called O2matic PRO100 that automatically adjusts oxygen levels to keep patients' blood oxygen levels in a specific range. Researchers will compare this system to the current method where

Who is the study for?

This trial is for patients with acute injuries or illnesses who need oxygen therapy. They must be in a hospital that can use the O2matic PRO100 system. There's no specific list of conditions, but they should require close monitoring of blood oxygen levels.

What is being tested?

The study tests if an automated machine called O2matic PRO100 can better control oxygen levels in the blood compared to standard manual adjustments by healthcare providers. Patients are randomly chosen to receive either the new device or usual care for 72 hours.

What are the potential side effects?

Since this trial involves a device to adjust oxygen delivery rather than a drug, side effects may include issues related to incorrect oxygen levels like dizziness, shortness of breath, or increased heart rate if the device doesn't work properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am hospitalized or will be for a major injury, burn, surgery, or severe respiratory issue.

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I need extra oxygen (1-10 liters per minute) due to low oxygen levels.

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I am 18 years old or older.

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I can start the trial within a day of getting to the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am about to receive advanced breathing support.

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I do not have conditions that make the PRO100 device unsafe for me.

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I plan to stop using extra oxygen soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of time spent within the targeted normoxemia range

Secondary study objectives

Amount of supplemental oxygen administered

Proportion of time spent in hyperoxemia (SpO2 >96%)

Proportion of time spent in hypoxemia (SpO2<88%)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (Automated Titration)Experimental Treatment1 Intervention

Patients randomized to the intervention arm will receive supplemental oxygen via nasal cannula (recommended up to 6 lpm) or face mask (recommended up to 15 lpm) and will have supplemental oxygen titrated using an autonomous oxygen titration system for the first 72 hours after randomization, or hospital discharge (whichever sooner).

Group II: Usual Care (Manual Titration)Active Control1 Intervention

Patients randomized to the usual care arm will receive usual care, manual oxygen titration, removal of supplemental oxygen, and escalation per hospital protocol, based on the site's usual SpO2 assessments. The SpO2 monitor for the O2matic PRO100 will also be connected to the patient in observation mode for data collection purposes only (not used for titration decisions).

0 / 7Eligibility criteria met