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Completed

NCT Number: NCT04824703

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

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

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Key information

Conditions

Oxygen Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aswan university hospital

Aswān, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug
  • 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

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

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

  2. Change in ejection fraction of heart in percentage

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

    percentage of blood that's pumped out of a filled ventricle with each heartbeat And measured by echocardiography

Secondary outcomes

  1. Acute respiratory distress syndrome

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

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

  2. Sepsis

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

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

  3. Stroke

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

    Cerebrovascular accidents

  4. Mechanical Ventilator free days

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

    Days without mechanical ventilation

  5. Shock

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

    Systolic blood pressure < 90 mmHg

  6. Surgery revision

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

    Surgical re exploration

  7. Vasopressor

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

    Use of vasopressors as norepinephrine and epinephrine

  8. ICU stay

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

    Duration of intensive care stay

  9. Hospital stay

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

    Duration of hospital stay

  10. Mortality

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

    Death of patient

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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