Completed

PILOTPragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial

What is being tested

Lower SpO2 Target

+ Intermediate SpO2 Target

+ Higher SpO2 Target

Other

Who is being recruted

Respiration Disorders

+ Respiratory Insufficiency

+ Respiratory Tract Diseases

Over 18 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2018

See protocol details

Summary

Principal SponsorVanderbilt University Medical Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2018

Actual date on which the first participant was enrolled.

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.

Official TitlePragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial

NCT03537937

Principal SponsorVanderbilt University Medical Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

2541 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Respiration DisordersRespiratory InsufficiencyRespiratory Tract Diseases

Criteria

3 inclusion criteria required to participate

Age ≥ 18 years

Receiving mechanical ventilation through an endotracheal tube or tracheostomy

Admitted to the study ICU or admission to the study ICU from the emergency department is planned

2 exclusion criteria prevent from participating

Known pregnancy or beta hCG level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant

Known to be a prisoner

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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 II

Active Comparator

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 III

Active Comparator

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%).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Vanderbilt University Medical Center

Nashville, United StatesOpen Vanderbilt University Medical Center in Google Maps

CompletedOne Study Center