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

Keywords

• Oxygen therapy and Mortality

Lead sponsor

Aswan University Hospital is the lead sponsor of 95 studies on the registry; 3 are open to participants now.

Eligibility criteria

Study arms

• Active comparator
  Conservative oxygen therapy

  * 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

• Placebo comparator
  Liberal oxygen therapy

  * 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

Interventions

• DrugOxygen

  * 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

Primary outcomes

1. Change in Stroke volume in milliliters

   Volume of blood in milliliters that is ejected from heart each second and measured By Echocardiography

   Time frame: Change from Baseline stroke volume At ICU admission and through study completion An average 6 months

2. 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

   Time frame: Change from baseline ejection fraction at icu admission and through study completion An Average 6 months

Secondary outcomes

1. Acute respiratory distress syndrome

   Acute persistent hypoxia with bilateral lung infiltrate due to non cardiac cause

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

2. Sepsis

   Systolic blood pressure \< 90 Respiratory rate \> 22 Heart rate \> 100

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

3. Stroke

   Cerebrovascular accidents

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

4. Mechanical Ventilator free days

   Days without mechanical ventilation

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

5. Shock

   Systolic blood pressure \< 90 mmHg

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

6. Surgery revision

   Surgical re exploration

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

7. Vasopressor

   Use of vasopressors as norepinephrine and epinephrine

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

8. ICU stay

   Duration of intensive care stay

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

9. Hospital stay

   Duration of hospital stay

   Time frame: From icu admission date to icu discharge date an average of 2 weeks

10. Mortality

    Death of patient

    Time frame: From icu admission date to icu discharge date an average of 2 weeks

Individual participant data

Plan to share: Yes