<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03287466</url>
  </required_header>
  <id_info>
    <org_study_id>UCL/16/0571</org_study_id>
    <nct_id>NCT03287466</nct_id>
  </id_info>
  <brief_title>Targeted OXYgen Therapy in Critical Illness</brief_title>
  <acronym>TOXYC</acronym>
  <official_title>A Randomised Controlled Trial of Targeted Oxygen Therapy in Mechanically Ventilated Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Free Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Free Charity</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to conduct a feasibility, multi-centre, randomised controlled trial&#xD;
      of targeted oxygen therapy in adult critically ill patients receiving mechanical ventilation&#xD;
      via an endotracheal tube as part of their treatment for respiratory failure. Participants&#xD;
      will be allocated to either a normal blood oxygen target group or a lower than normal blood&#xD;
      oxygen target group. The primary purpose of the study will be to assess the feasibility of&#xD;
      recruiting complex patients who lack capacity into a clinical trial in which oxygenation is&#xD;
      being assessed, and that the clinicians responsible for these patients are able to deliver&#xD;
      the intervention effectively. The safety of using a lower than normal blood oxygen target&#xD;
      will also be assessed and blood samples taken for subsequent investigation of the biological&#xD;
      mechanisms underlying the observed changes.&#xD;
&#xD;
      Participants will be randomised (1:1) into either an intervention or control group. The&#xD;
      intervention in this trial is tightly controlled administration of oxygen to patients to&#xD;
      achieve a haemoglobin oxygen saturation (SpO2) of 88-92%. The control group will also have&#xD;
      tightly controlled oxygen administration, but to achieve an SpO2 of 96% or above. The target&#xD;
      for the control group represents a normal SpO2, whilst that in the intervention group is&#xD;
      lower than what is considered to be normal. It should be noted that although lower than&#xD;
      normal, this SpO2 is close to what the general public experience when travelling by&#xD;
      pressurised aircraft as the fractional inspired oxygen concentration in that situation is&#xD;
      only 0.15-0.17 (15-17%).&#xD;
&#xD;
      The controlled oxygen administration would commence as soon as possible after admission to&#xD;
      the critical care unit and end following removal of the participant's artificial breathing&#xD;
      tube. The researchers and clinical team cannot be blinded to treatment allocation, due to the&#xD;
      nature of the intervention. Those analysing the data will be blinded to the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim is to determine whether revising standard targets for blood oxygen&#xD;
      levels in patients requiring artificial ventilation on a critical care unit is feasible and&#xD;
      whether this affects specific blood biomarker levels.&#xD;
&#xD;
      Investigators in this area of expertise currently lack the information necessary to determine&#xD;
      how much oxygen should be given to adult critically ill patients on a mechanical ventilator&#xD;
      to assist their breathing in order to achieve the best clinical outcomes i.e. minimal&#xD;
      morbidity and mortality. Excessive oxygen administration (both its concentration and&#xD;
      duration) and hyperoxaemia (an excessively high blood oxygen level) are known to be harmful&#xD;
      to critically ill patients. The reason for this is that oxygen in high concentration is&#xD;
      toxic, because it results in the release of molecules called reactive oxygen species (ROS).&#xD;
      ROS lead to a state known as 'oxidative stress', in which cells and tissues are rapidly&#xD;
      destroyed by these destructive molecules.&#xD;
&#xD;
      The difficulty with treating critically ill patients is that they are usually extremely&#xD;
      unwell, requiring artificial ventilation to support their breathing. Unfortunately, these&#xD;
      patients appear to be exceptionally prone to the harms of oxidative stress, leading to&#xD;
      permanent damage of their lungs. Yet it is precisely this group of patients who require high&#xD;
      concentration oxygen to keep their blood oxygen levels within the normal. It has therefore&#xD;
      been hypothesised that using lower blood oxygen targets than usual may be beneficial to these&#xD;
      patients through the avoidance of excessively high concentrations of oxygen. The investigator&#xD;
      proposes that in mechanically ventilated critically ill patients harm (morbidity and&#xD;
      mortality) will be reduced by using 'targeted oxygen therapy' (TO2T) to achieve lower blood&#xD;
      oxygen levels than normal when compared to standard practice (normal blood oxygen levels).&#xD;
      The levels are only moderately lower than normal and well within what most clinicians would&#xD;
      consider to be safe in these patients.&#xD;
&#xD;
      Prior to any large-scale study, it is important to understand if this approach to managing&#xD;
      critically ill patients is feasible. This prospective, dual site randomised controlled trial&#xD;
      will therefore establish whether it is possible to conduct a trial in which blood oxygen&#xD;
      levels are carefully titrated by the critical care team, to achieve specific targets.&#xD;
      Participants will be allocated into one of two groups: i) normal blood oxygen levels, and ii)&#xD;
      low blood oxygen levels. For the time that participants are artificially ventilated by a&#xD;
      breathing (endotracheal) tube, they will remain in their allocated treatment group.&#xD;
      Information will be collected from the patient's charts and records during their stay on the&#xD;
      CCU to assess the impact of the treatment. A series of blood samples will also be collected&#xD;
      from participants to quantify the degree of oxidative stress through the measurement of&#xD;
      several specific biomarkers. A total of 60 patients will be enrolled at two sites.&#xD;
&#xD;
      As oxygen is a drug that is administered to almost every patient admitted to a critical care&#xD;
      unit (CCU), it is imperative that decisions regarding oxygenation are based upon evidence&#xD;
      rather than conjecture. Limited work has been undertaken to date to understand whether&#xD;
      lowering blood oxygen levels is achievable in this complex patient group. The information&#xD;
      from this study will be used to design a subsequent much larger study to fully evaluate&#xD;
      whether TO2T to achieve lower blood oxygen levels saves lives in critically ill patients. If&#xD;
      lower blood oxygen levels improve survival in critically ill patients implementation of this&#xD;
      intervention could have an immediate and cost-effective impact across the entire National&#xD;
      Health Service.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>feasibility, multi-centre, randomised controlled trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Clinicians and other healthcare providers will not be blinded to treatment allocation, nor will the clinical research team. This is because knowing the patient's blood oxygen level is an essential component of the study. Those members of the research team analysing data after the recruitment phase of the study will be blinded to group allocation. Participants will not be blinded but are unlikely to be aware to their allocation due to the severity of their illness.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility to recruit</measure>
    <time_frame>15 Months</time_frame>
    <description>Ability to recruit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of arterial blood gases</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of arterial blood gases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of oxygen saturation</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of fraction of inspired oxygen</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of fraction of inspired oxygen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to extubation / detachment from mechanical ventilation</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Time to extubation / detachment from mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation free days on ICU</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Mechanical ventilation free days on ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of blood pressure</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of heart rate</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of cardiac rhythm</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of cardiac rhythm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of cardiac output and stroke volume (if measured)</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of cardiac output and stroke volume (if measured)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of vasopressor doses</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of vasopressor doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of inotrope doses</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of inotrope doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of daily fluid balance</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of daily fluid balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of inotrope free days on ICU</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of inotrope free days on ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of vasopressor free days on ICU</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of vasopressor free days on ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Urea</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of Urea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of creatinine</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of urine output</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of urine output</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need for renal replacement therapy</measure>
    <time_frame>up to 21 days</time_frame>
    <description>The need for renal replacement therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal replacement therapy free days on ICU</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Renal replacement therapy free days on ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of transaminases</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of transaminases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of blood clotting values</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of blood clotting values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of bilirubin</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of blood lactate</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of blood lactate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Troponin</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measurement of Troponin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>90 days</time_frame>
    <description>Adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA score change</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Sequential Organ Failure Assessment (SOFA) score change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APACHE II score change</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Acute Physiology and Chronic Health Evaluation (APACHE) II score change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Length of stay in intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>90 days</time_frame>
    <description>Length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rates</measure>
    <time_frame>90 days</time_frame>
    <description>Days alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days alive out of Hospital</measure>
    <time_frame>90 days</time_frame>
    <description>Days alive out of Hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Critical Illness</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>SpO2 88-92%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is targeted oxygen therapy (TO2T) to achieve an arterial haemoglobin oxygen saturation (SpO2) of 88-92%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Current best practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will have no specific SpO2 targets. Clinicians will be able to target SpO2 according to parameters they feel are suitable for the patient, according to standard UK practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>targeted oxygen therapy</description>
    <arm_group_label>Current best practice</arm_group_label>
    <arm_group_label>SpO2 88-92%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unplanned admission to a critical care unit&#xD;
&#xD;
          -  18 years of age and above (no upper age limit)&#xD;
&#xD;
          -  Respiratory failure forms part of the admission diagnosis&#xD;
&#xD;
          -  The patient is mechanically ventilated via an endotracheal tube&#xD;
&#xD;
          -  The patient is expected to receive mechanical ventilation for &gt; 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admission following surgery (elective or unplanned)&#xD;
&#xD;
          -  Those patients expected to die within 24 hours of admission to ICU *&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Admission post-cardiac arrest&#xD;
&#xD;
          -  Admission post trauma (including traumatic brain injury)&#xD;
&#xD;
          -  Known sickle cell trait or disease&#xD;
&#xD;
          -  Ongoing significant haemorrhage or profound anaemia&#xD;
&#xD;
          -  Severe peripheral vascular disease&#xD;
&#xD;
          -  Severe pulmonary hypertension&#xD;
&#xD;
          -  Other medical conditions where mild hypoxaemia would be contra-indicated ***&#xD;
&#xD;
          -  Patients participating in other interventional clinical trials&#xD;
&#xD;
               -  As determined by the responsible clinical team ** As determined by the&#xD;
                  responsible clinical team and /or research team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oxygen</keyword>
  <keyword>oxygen saturation</keyword>
  <keyword>oxygen concentration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287466
org study id: UCL/16/0571
nct id: NCT03287466
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators propose to conduct a feasibility, multi-centre, randomised controlled trial
      of targeted oxygen therapy in adult critically ill patients receiving mechanical ventilation
      via an endotracheal tube as part of their treatment for respiratory failure. Participants
      will be allocated to either a normal blood oxygen target group or a lower than normal blood
      oxygen target group. The primary purpose of the study will be to assess the feasibility of
      recruiting complex patients who lack capacity into a clinical trial in which oxygenation is
      being assessed, and that the clinicians responsible for these patients are able to deliver
      the intervention effectively. The safety of using a lower than normal blood oxygen target
      will also be assessed and blood samples taken for subsequent investigation of the biological
      mechanisms underlying the observed changes.

      Participants will be randomised (1:1) into either an intervention or control group. The
      intervention in this trial is tightly controlled administration of oxygen to patients to
      achieve a haemoglobin oxygen saturation (SpO2) of 88-92%. The control group will also have
      tightly controlled oxygen administration, but to achieve an SpO2 of 96% or above. The target
      for the control group represents a normal SpO2, whilst that in the intervention group is
      lower than what is considered to be normal. It should be noted that although lower than
      normal, this SpO2 is close to what the general public experience when travelling by
      pressurised aircraft as the fractional inspired oxygen concentration in that situation is
      only 0.15-0.17 (15-17%).

      The controlled oxygen administration would commence as soon as possible after admission to
      the critical care unit and end following removal of the participant's artificial breathing
      tube. The researchers and clinical team cannot be blinded to treatment allocation, due to the
      nature of the intervention. Those analysing the data will be blinded to the intervention.
The investigators aim is to determine whether revising standard targets for blood oxygen
      levels in patients requiring artificial ventilation on a critical care unit is feasible and
      whether this affects specific blood biomarker levels.

      Investigators in this area of expertise currently lack the information necessary to determine
      how much oxygen should be given to adult critically ill patients on a mechanical ventilator
      to assist their breathing in order to achieve the best clinical outcomes i.e. minimal
      morbidity and mortality. Excessive oxygen administration (both its concentration and
      duration) and hyperoxaemia (an excessively high blood oxygen level) are known to be harmful
      to critically ill patients. The reason for this is that oxygen in high concentration is
      toxic, because it results in the release of molecules called reactive oxygen species (ROS).
      ROS lead to a state known as 'oxidative stress', in which cells and tissues are rapidly
      destroyed by these destructive molecules.

      The difficulty with treating critically ill patients is that they are usually extremely
      unwell, requiring artificial ventilation to support their breathing. Unfortunately, these
      patients appear to be exceptionally prone to the harms of oxidative stress, leading to
      permanent damage of their lungs. Yet it is precisely this group of patients who require high
      concentration oxygen to keep their blood oxygen levels within the normal. It has therefore
      been hypothesised that using lower blood oxygen targets than usual may be beneficial to these
      patients through the avoidance of excessively high concentrations of oxygen. The investigator
      proposes that in mechanically ventilated critically ill patients harm (morbidity and
      mortality) will be reduced by using 'targeted oxygen therapy' (TO2T) to achieve lower blood
      oxygen levels than normal when compared to standard practice (normal blood oxygen levels).
      The levels are only moderately lower than normal and well within what most clinicians would
      consider to be safe in these patients.

      Prior to any large-scale study, it is important to understand if this approach to managing
      critically ill patients is feasible. This prospective, dual site randomised controlled trial
      will therefore establish whether it is possible to conduct a trial in which blood oxygen
      levels are carefully titrated by the critical care team, to achieve specific targets.
      Participants will be allocated into one of two groups: i) normal blood oxygen levels, and ii)
      low blood oxygen levels. For the time that participants are artificially ventilated by a
      breathing (endotracheal) tube, they will remain in their allocated treatment group.
      Information will be collected from the patient's charts and records during their stay on the
      CCU to assess the impact of the treatment. A series of blood samples will also be collected
      from participants to quantify the degree of oxidative stress through the measurement of
      several specific biomarkers. A total of 60 patients will be enrolled at two sites.

      As oxygen is a drug that is administered to almost every patient admitted to a critical care
      unit (CCU), it is imperative that decisions regarding oxygenation are based upon evidence
      rather than conjecture. Limited work has been undertaken to date to understand whether
      lowering blood oxygen levels is achievable in this complex patient group. The information
      from this study will be used to design a subsequent much larger study to fully evaluate
      whether TO2T to achieve lower blood oxygen levels saves lives in critically ill patients. If
      lower blood oxygen levels improve survival in critically ill patients implementation of this
      intervention could have an immediate and cost-effective impact across the entire National
      Health Service.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: feasibility, multi-centre, randomised controlled trial
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Clinicians and other healthcare providers will not be blinded to treatment allocation, nor will the clinical research team. This is because knowing the patient's blood oxygen level is an essential component of the study. Those members of the research team analysing data after the recruitment phase of the study will be blinded to group allocation. Participants will not be blinded but are unlikely to be aware to their allocation due to the severity of their illness.
measure: Feasibility to recruit
time frame: 15 Months
description: Ability to recruit
measure: Measurement of arterial blood gases
time frame: up to 21 days
description: Measurement of arterial blood gases
measure: Measurement of oxygen saturation
time frame: up to 21 days
description: Measurement of oxygen saturation
measure: Measurement of fraction of inspired oxygen
time frame: up to 21 days
description: Measurement of fraction of inspired oxygen
measure: Time to extubation / detachment from mechanical ventilation
time frame: up to 21 days
description: Time to extubation / detachment from mechanical ventilation
measure: Mechanical ventilation free days on ICU
time frame: up to 21 days
description: Mechanical ventilation free days on ICU
measure: Measurement of blood pressure
time frame: up to 21 days
description: Measurement of blood pressure
measure: Measurement of heart rate
time frame: up to 21 days
description: Measurement of heart rate
measure: Measurement of cardiac rhythm
time frame: up to 21 days
description: Measurement of cardiac rhythm
measure: Measurement of cardiac output and stroke volume (if measured)
time frame: up to 21 days
description: Measurement of cardiac output and stroke volume (if measured)
measure: Measurement of vasopressor doses
time frame: up to 21 days
description: Measurement of vasopressor doses
measure: Measurement of inotrope doses
time frame: up to 21 days
description: Measurement of inotrope doses
measure: Measurement of daily fluid balance
time frame: up to 21 days
description: Measurement of daily fluid balance
measure: Measurement of inotrope free days on ICU
time frame: up to 21 days
description: Measurement of inotrope free days on ICU
measure: Measurement of vasopressor free days on ICU
time frame: up to 21 days
description: Measurement of vasopressor free days on ICU
measure: Measurement of Urea
time frame: up to 21 days
description: Measurement of Urea
measure: Measurement of creatinine
time frame: up to 21 days
description: Measurement of creatinine
measure: Measurement of urine output
time frame: up to 21 days
description: Measurement of urine output
measure: The need for renal replacement therapy
time frame: up to 21 days
description: The need for renal replacement therapy
measure: Renal replacement therapy free days on ICU
time frame: up to 21 days
description: Renal replacement therapy free days on ICU
measure: Measurement of transaminases
time frame: up to 21 days
description: Measurement of transaminases
measure: Measurement of blood clotting values
time frame: up to 21 days
description: Measurement of blood clotting values
measure: Measurement of bilirubin
time frame: up to 21 days
description: Measurement of bilirubin
measure: Measurement of blood lactate
time frame: up to 21 days
description: Measurement of blood lactate
measure: Measurement of Troponin
time frame: up to 21 days
description: Measurement of Troponin
measure: Adverse events
time frame: 90 days
description: Adverse events
measure: SOFA score change
time frame: up to 21 days
description: Sequential Organ Failure Assessment (SOFA) score change
measure: APACHE II score change
time frame: up to 21 days
description: Acute Physiology and Chronic Health Evaluation (APACHE) II score change
measure: Length of ICU stay
time frame: up to 21 days
description: Length of stay in intensive care unit
measure: Length of hospital stay
time frame: 90 days
description: Length of hospital stay
measure: Mortality rates
time frame: 90 days
description: Days alive
measure: Days alive out of Hospital
time frame: 90 days
description: Days alive out of Hospital
arm group label: SpO2 88-92%
arm group type: Experimental
description: The intervention is targeted oxygen therapy (TO2T) to achieve an arterial haemoglobin oxygen saturation (SpO2) of 88-92%.
arm group label: Current best practice
arm group type: Active Comparator
description: The control group will have no specific SpO2 targets. Clinicians will be able to target SpO2 according to parameters they feel are suitable for the patient, according to standard UK practice.
intervention type: Drug
intervention name: Oxygen
description: targeted oxygen therapy
arm group label: Current best practice
arm group label: SpO2 88-92%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Critical Illness
sharing ipd: No