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

Oxygen Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824703
• Other study ID #: Aswu/460/5/20
• Status: Completed
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: May 11, 2023

Study information

• Verified date: April 2024
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 11, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oxygen Therapy

Intervention

Drug:
• Oxygen
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

Locations

Country	Name	City	State
Egypt	Aswan university hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Sepsis	Systolic blood pressure < 90 Respiratory rate > 22 Heart rate > 100	From icu admission date to icu discharge date an average of 2 weeks
Secondary	Stroke	Cerebrovascular accidents	From icu admission date to icu discharge date an average of 2 weeks
Secondary	Mechanical Ventilator free days	Days without mechanical ventilation	From icu admission date to icu discharge date an average of 2 weeks
Secondary	Shock	Systolic blood pressure < 90 mmHg	From icu admission date to icu discharge date an average of 2 weeks
Secondary	Surgery revision	Surgical re exploration	From icu admission date to icu discharge date an average of 2 weeks
Secondary	Vasopressor	Use of vasopressors as norepinephrine and epinephrine	From icu admission date to icu discharge date an average of 2 weeks
Secondary	ICU stay	Duration of intensive care stay	From icu admission date to icu discharge date an average of 2 weeks
Secondary	Hospital stay	Duration of hospital stay	From icu admission date to icu discharge date an average of 2 weeks
Secondary	Mortality	Death of patient	From icu admission date to icu discharge date an average of 2 weeks