Pragmatic Investigation of optimaL Oxygen Targets Trial

Respiratory Failure Clinical Trial

— PILOT  

Official title:

Pragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537937
• Other study ID #: 171272
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2541
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Lower SpO2 Target
SpO2 target 90% (range 88-92%)
• Intermediate SpO2 Target
SpO2 target 94% (range 92-96%)
• Higher SpO2 Target
SpO2 target 98% (range 96-100%)

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atrial Arrhythmia (Exploratory Safety Outcome)	Documented atrial arrhythmia	28 days
Other	Ventricular Arrhythmia (Exploratory Safety Outcome)	Documented ventricular arrhythmia	28 days
Other	Cardiac Arrest (Exploratory Safety Outcome)	Cardiac arrest with return of spontaneous circulation	28 days
Other	Pneumothorax or Pneumomediastinum (Exploratory Safety Outcome)	Pneumothorax or pneumomediastinum as defined by documentation in the electronic health record by treating clinicians or radiology of a pneumothorax on thoracic imaging or thoracic ultrasound.	28 days
Other	Ischemic Stroke (Exploratory Safety Outcome)	New ischemic stroke between enrollment and 28 days after enrollment as diagnosed by computed tomography, magnetic resonance imaging, or cerebral angiography.	28 days
Other	Myocardial Infarction (Exploratory Safety Outcome)	New myocardial infarction between enrollment and 28 days after enrollment, defined as detection of a rise in cardiac troponin values with at least one value above the 99th percentile and clinical evidence of acute myocardial ischemia.	28 days
Primary	Ventilator-free Days (VFDs) to Study Day 28	Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.	28 days
Secondary	28-day, In-hospital Mortality (Secondary Outcome)	All-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment (Secondary Outcome).	28 days
Secondary	Intensive Care Unit Mortality (Exploratory Clinical Outcome)	All-cause mortality prior to transfer out of the intensive care unit	28 days
Secondary	Vasopressor-free Days (Exploratory Clinical Outcome)	Number of days alive and free from vasopressor receipt between the final receipt of vasopressors before 28 days and study day 28.	28 days
Secondary	Renal Replacement Therapy-free Days (Exploratory Clinical Outcome)	Number of days alive and free from renal replacement therapy between the final receipt of renal replacement therapy before 28 days and study day 28	28 days
Secondary	Intensive Care Unit-free Days (Exploratory Clinical Outcome)	Number of days alive and free from intensive care unit admission after the final transfer out of the intensive care unit before 28 days to study day 28	28 days
Secondary	Hospital-free Days (Exploratory Clinical Outcome)	Number of days alive and free from hospital admission to study day 28	28 days
Secondary	Acute Kidney Injury (AKI) (Exploratory Organ Function Outcome)	Presence of Stage II or greater AKI by Kidney Disease: Improving Global Outcomes (KDIGO) criteria	28 days