Pragmatic Investigation of optimaL Oxygen Targets Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2022-01-31

Brief Summary

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Mechanical ventilation of ICU patients universally involves titration of the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU practice, however, the optimal SpO2 target remains unknown. Current guidelines offer divergent recommendations as to the optimal SpO2 target. Therefore, we propose a 2,250-patient cluster-randomized cluster-crossover trial comparing a lower SpO2 target (90%; range 88-92%), an intermediate SpO2 target (94%; range 92-96%), and a higher SpO2 target (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical ventilation.

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Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In the PILOT trial, the entire study ICU will be assigned to a single SpO2 target (cluster-randomized) and the ICU will switch between lower, intermediate, and higher SpO2 targets every two months in a randomly generated sequence (cluster-crossover).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Observer bias will be minimized by use of objective endpoints collected in duplicate by \[1\] study personnel blinded to group assignment and \[2\] automated data extraction from the electronic health record.

Study Groups

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Lower SpO2 Target

During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 90% (range 88-92%).

Group Type ACTIVE_COMPARATOR

Lower SpO2 Target

Intervention Type OTHER

SpO2 target 90% (range 88-92%)

Intermediate SpO2 Target

During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 94% (range 92-96%).

Group Type ACTIVE_COMPARATOR

Intermediate SpO2 Target

Intervention Type OTHER

SpO2 target 94% (range 92-96%)

Higher SpO2 Target

During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 98% (range 96-100%).

Group Type ACTIVE_COMPARATOR

Higher SpO2 Target

Intervention Type OTHER

SpO2 target 98% (range 96-100%)

Interventions

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Lower SpO2 Target

SpO2 target 90% (range 88-92%)

Intervention Type OTHER

Intermediate SpO2 Target

SpO2 target 94% (range 92-96%)

Intervention Type OTHER

Higher SpO2 Target

SpO2 target 98% (range 96-100%)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Receiving mechanical ventilation through an endotracheal tube or tracheostomy
3. Admitted to the study ICU or admission to the study ICU from the emergency department is planned

Exclusion Criteria

1. Known pregnancy or beta hCG level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant
2. Known to be a prisoner

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No