Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04824703
Enrollment
106
Registered
2021-04-01
Start date
2021-04-05
Completion date
2023-05-11
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen Therapy

Keywords

Oxygen therapy and Mortality

Brief summary

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

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

Sponsors

Aswan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Stroke volume in millilitersChange from Baseline stroke volume At ICU admission and through study completion An average 6 monthsVolume of blood in milliliters that is ejected from heart each second and measured By Echocardiography
Change in ejection fraction of heart in percentageChange from baseline ejection fraction at icu admission and through study completion An Average 6 monthspercentage of blood that's pumped out of a filled ventricle with each heartbeat And measured by echocardiography

Secondary

MeasureTime frameDescription
StrokeFrom icu admission date to icu discharge date an average of 2 weeksCerebrovascular accidents
Mechanical Ventilator free daysFrom icu admission date to icu discharge date an average of 2 weeksDays without mechanical ventilation
ShockFrom icu admission date to icu discharge date an average of 2 weeksSystolic blood pressure \< 90 mmHg
Surgery revisionFrom icu admission date to icu discharge date an average of 2 weeksSurgical re exploration
Acute respiratory distress syndromeFrom icu admission date to icu discharge date an average of 2 weeksAcute persistent hypoxia with bilateral lung infiltrate due to non cardiac cause
ICU stayFrom icu admission date to icu discharge date an average of 2 weeksDuration of intensive care stay
Hospital stayFrom icu admission date to icu discharge date an average of 2 weeksDuration of hospital stay
MortalityFrom icu admission date to icu discharge date an average of 2 weeksDeath of patient
VasopressorFrom icu admission date to icu discharge date an average of 2 weeksUse of vasopressors as norepinephrine and epinephrine
SepsisFrom icu admission date to icu discharge date an average of 2 weeksSystolic blood pressure \< 90 Respiratory rate \> 22 Heart rate \> 100

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026