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Pragmatic Investigation of optimaL Oxygen Targets Trial (PILOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537937
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew Semler, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Other: Lower SpO2 Target Other: Intermediate SpO2 Target Other: Higher SpO2 Target Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2541 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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).
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Pragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : January 31, 2022
Actual Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: 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%).
Other: Lower SpO2 Target
SpO2 target 90% (range 88-92%)

Active Comparator: 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%).
Other: Intermediate SpO2 Target
SpO2 target 94% (range 92-96%)

Active Comparator: 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%).
Other: Higher SpO2 Target
SpO2 target 98% (range 96-100%)




Primary Outcome Measures :
  1. Ventilator-free days (VFDs) to study day 28 [ Time Frame: 28 days ]
    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.


Secondary Outcome Measures :
  1. 28-day, in-hospital Mortality (Secondary Outcome) [ Time Frame: 28 days ]
    All-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment (Secondary Outcome).

  2. Intensive Care Unit Mortality (Exploratory Clinical Outcome) [ Time Frame: 28 days ]
    All-cause mortality prior to transfer out of the intensive care unit

  3. Vasopressor-free days (Exploratory Clinical Outcome) [ Time Frame: 28 days ]
    Number of days alive and free from vasopressor receipt between the final receipt of vasopressors before 28 days and study day 28.

  4. Renal replacement therapy-free days (Exploratory Clinical Outcome) [ Time Frame: 28 days ]
    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

  5. Intensive care unit-free days (Exploratory Clinical Outcome) [ Time Frame: 28 days ]
    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

  6. Hospital-free days (Exploratory Clinical Outcome) [ Time Frame: 28 days ]
    Number of days alive and free from hospital admission to study day 28

  7. Daily non-respiratory Sequential Organ Failure Assessment (SOFA) Score (Exploratory Organ Function Outcome) [ Time Frame: 28 days ]
    The Sequential Organ Failure Assessment (SOFA) score (Vincent et al Critical Care Medicine 1998) is composed of scores from six organ systems, graded from 0 to 4 according to the degree of dysfunction or failure. Scores range from 0 (no evidence of organ dysfunction or failure) to 24 (evidence of severe dysfunction failure in each of the six organ systems). The modified non-respiratory SOFA score is composed of scores from five of the six organ systems included in the complete SOFA score (excluding the respiratory system), graded on the same scale as the complete SOFA score. Scores range from 0 (no evidence of organ dysfunction or failure) to 20 (evidence of severe organ dysfunction or failure in each of the five organ systems assessed).

  8. Plasma creatinine (Exploratory Organ Function Outcome) [ Time Frame: 28 days ]
    Daily plasma creatinine value (mg/dL)

  9. Plasma lactate (Exploratory Organ Function Outcome) [ Time Frame: 28 days ]
    Daily plasma lactate value (mmol/L)

  10. Acute respiratory distress syndrome (ARDS) (Exploratory Organ Function Outcome) [ Time Frame: 28 days ]
    Presence of ARDS by Berlin Criteria

  11. Acute Kidney Injury (AKI) (Exploratory Organ Function Outcome) [ Time Frame: 28 days ]
    Presence of Stage II or greater AKI by Kidney Disease: Improving Global Outcomes (KDIGO) criteria


Other Outcome Measures:
  1. Atrial arrhythmia (Exploratory Safety Outcome) [ Time Frame: 28 days ]
    Documented atrial arrhythmia

  2. Ventricular arrhythmia (Exploratory Safety Outcome) [ Time Frame: 28 days ]
    Documented ventricular arrhythmia

  3. Cardiac arrest (Exploratory Safety Outcome) [ Time Frame: 28 days ]
    Cardiac arrest with return of spontaneous circulation

  4. Pneumothorax or pneumomediastinum (Exploratory Safety Outcome) [ Time Frame: 28 days ]
    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.

  5. Ischemic stroke (Exploratory Safety Outcome) [ Time Frame: 28 days ]
    New ischemic stroke between enrollment and 28 days after enrollment as diagnosed by computed tomography, magnetic resonance imaging, or cerebral angiography.

  6. Myocardial infarction (Exploratory Safety Outcome) [ Time Frame: 28 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537937


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Matthew W Semler, MD Vanderbilt University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Semler, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03537937    
Other Study ID Numbers: 171272
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The NIH's guidelines for data sharing will serve as the model for the approach we will follow for the proposed investigation;

http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm

Even though the final dataset will be stripped of identifiers prior to release for sharing, the inherent link between the period in which the patient was admitted to the study ICU and group assignment in a cluster-crossover trial introduces a significant risk for deductive disclosure of subjects. Thus, we will make the data and associated documentation available to users only under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases