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

Aswan University Hospital

Status: Completed

Conditions: Oxygen Therapy

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04824703

Aswu/460/5/20

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Conservative oxygen therapy

Active Comparator group

Description:

* 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

Treatment:

Drug: Oxygen

Liberal oxygen therapy

Placebo Comparator group

Description:

* 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

Treatment:

Drug: Oxygen