Clinical trial

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

Name

Aswu/460/5/20

Description

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

Trial arms

Trial start

2021-04-05

Estimated PCD

2023-05-05

Trial end

2023-05-11

Status

Completed

Treatment

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

Arms:

Conservative oxygen therapy, Liberal oxygen therapy

Size

106

Primary endpoint

Change in Stroke volume in milliliters

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

Change in ejection fraction of heart in percentage

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 106, 'type': 'ACTUAL'}}

Updated at

2024-04-30

1 organization

1 product

1 indication

Organization

Aswan University Hospital

Product

Oxygen

Indication

Oxygen Therapy