Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admission to ICU and requiring invasive mechanical ventilation

Disqualifiers

Prisoners

Patients receiving mechanical ventilation for less than twelve hours

Trial design

Design model

Single group

Treatments tested in this trial

  • Education

    Other intervention

    1\) Standardized materials to discuss the rationale and procedural aspects of the intervention, including details on the specific oxygen target-related modifications to the mechanical ventilation order-set prior to starting the intervention phase.

  • Epic notification alert

    Behavioral

    An education-based intervention that focuses on mitigating Occult Hypoxemia in mechanically ventilated patients and thus utilizes the same patient population. The second intervention will notify the clinical team to an abnormal laboratory result in real time. This laboratory result is already located in the patient's Epic chart under arterial blood gas (ABG), arterial oxygen saturation (Sa02) Patient level randomization will occur in Epic to as 1. alert (notification) the providers of sustained occult hypoxemia 2. silent alert

Treatment groups

3,600 Participants
are divided into 2 treatment groups
Group A: Educational interventionOther 1 intervention
Group B: Educational intervention Epic alertOther 1 intervention

Trial outcomes

Primary outcomes

1

Ventilator Free Days (Phase I,II)

The number of days the patient will be free of mechanical ventilation

Time frame
30 Days

Secondary outcomes

1

instances of occult hypoxemia (Phase I,II)

arterial oxygen saturation below 88% when the Sp02 is greater than 90% among all patients

Time frame
30 days
2

ICU free days (Phase I,II)

Number of days patients are not in the ICU

Time frame
90 days
3

Hospital free days (Phase I, II)

number of days patients are not hospitalized

Time frame
90 DAYS
4

90 Day in hospital mortality (Phase I, II)

Patients that die in the hospital before day 90

Time frame
90 days

Other outcomes

1

Proportion of mechanically ventilated time on SpO₂ protocol target (Phase I, II)

Reported between index intubation and 30 days later. The SpO₂ protocol target is defined as SpO₂ 90-96% or receiving no oxygen (FiO₂ 0.21 with SpO₂\>96%) or maximal oxygen (FiO₂ 1.00, with SpO₂ below 90%) while requiring mechanical ventilation.

Time frame
30 days
2

Proportion of participants receiving high levels of oxygen support (FiO₂ >0.80) (Phase I, II)

Defined as \>2 hours while requiring mechanical ventilation. This includes only the time the patient is in the ICU and receiving any amount of respiratory support (IMV or otherwise).

Time frame
30 days
3

Proportion of time at high levels of oxygen support (FiO₂ >0.80) (Phase I, II)

Quantified during mechanical ventilation.

Time frame
30 days
4

Proportion of time receiving room air oxygen (FiO₂ 0.21) (Phase I, II)

Quantified during mechanical ventilation.

Time frame
30 days

Sponsors and contacts

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