Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients

Study Overview
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Brief Summary
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To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients

Official Title
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Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients

Conditions
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Oxygen Therapy

Intervention / Treatment
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* Drug: Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults aged 18 years or older admitted to ICU and expected to receive mechanical ventilation beyond next calendar day Exclusion Criteria: inclusion in other trial severe acute respiratory distress syndrome at time of admission acute Chronic obstructive airway disease exacerbation pregnancy Carbon monoxide poisoning Guillain Barre syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative oxygen therapy<br>Spo2 alarm limit will be set as follow: - upper limit 94% and lower limit 88% If spo2 >94% Unless fio2 is 0.21%, decrease fio2 by 0.10% at intervals no longer than 5 minutes till spo2 = 94% If spo2 within target Decrease fio2 0.05% at intervals no longer than 30 min till fio2 0.21% reached or spo2 = 88 % If spo2 < 88 % return to previous spo2 that achieve target spo2. if an arterial blood gas demonstrate that the PaO2 is < 60 mmHg FiO2 will increased if clinically appropriate irrespective of the SpO2 reading ( target po2 60-100 mmhg ) During intubation, airway suction, tracheostomy, bronchoscopy, transportation outside of the ICU for radiological or other investigations or for procedures or operations, other critical situations such as hemodynamic collapse, patients will receive standard (non-study)treatment. Echocardiography on randomization and at end of the study: we will calculate stroke volume according to Simpson's apical four view | Drug: Oxygen<br>* Decreasing fraction of inspired oxygen and its effect on mortality and myocardial function administered by invasive mechanical ventilation with fraction of inspired oxygen between 0.21 and 1<br>|
| Placebo Comparator: Liberal oxygen therapy<br>Spo2 target > 95% No specific measures will be taken to avoid high fio2 or high po2 Use of upper alarm limit for spo2 will be prohibited Echocardiography on randomization and at end of the study: we will calculate stroke volume according to Simpson's apical four view | Drug: Oxygen<br>* Decreasing fraction of inspired oxygen and its effect on mortality and myocardial function administered by invasive mechanical ventilation with fraction of inspired oxygen between 0.21 and 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stroke volume in milliliters | Volume of blood in milliliters that is ejected from heart each second and measured By Echocardiography | Change from Baseline stroke volume At ICU admission and through study completion An average 6 months | 
| Change in ejection fraction of heart in percentage | percentage of blood that's pumped out of a filled ventricle with each heartbeat And measured by echocardiography | Change from baseline ejection fraction at icu admission and through study completion An Average 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute respiratory distress syndrome | Acute persistent hypoxia with bilateral lung infiltrate due to non cardiac cause | From icu admission date to icu discharge date an average of 2 weeks | 
| Sepsis | Systolic blood pressure < 90 Respiratory rate > 22 Heart rate > 100 | From icu admission date to icu discharge date an average of 2 weeks | 
| Stroke | Cerebrovascular accidents | From icu admission date to icu discharge date an average of 2 weeks | 
| Mechanical Ventilator free days | Days without mechanical ventilation | From icu admission date to icu discharge date an average of 2 weeks | 
| Shock | Systolic blood pressure < 90 mmHg | From icu admission date to icu discharge date an average of 2 weeks | 
| Surgery revision | Surgical re exploration | From icu admission date to icu discharge date an average of 2 weeks | 
| Vasopressor | Use of vasopressors as norepinephrine and epinephrine | From icu admission date to icu discharge date an average of 2 weeks | 
| ICU stay | Duration of intensive care stay | From icu admission date to icu discharge date an average of 2 weeks | 
| Hospital stay | Duration of hospital stay | From icu admission date to icu discharge date an average of 2 weeks | 
| Mortality | Death of patient | From icu admission date to icu discharge date an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen therapy and Mortality