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

Not Applicable

Completed

• Conditions: Oxygen Therapy
• Interventions: Drug: Oxygen

• Registration Number: NCT04824703
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Study Start: 2021-04-05
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• adults aged 18 years or older admitted to ICU and expected to receive mechanical ventilation beyond next calendar day

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative oxygen therapy	Oxygen	* 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
Liberal oxygen therapy	Oxygen	* 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

Primary Outcome Measures

Name	Time	Method
Change in ejection fraction of heart in percentage	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
Change in Stroke volume in milliliters	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

Secondary Outcome Measures

Name	Time	Method
Sepsis	From icu admission date to icu discharge date an average of 2 weeks	Systolic blood pressure \< 90 Respiratory rate \> 22 Heart rate \> 100
Stroke	From icu admission date to icu discharge date an average of 2 weeks	Cerebrovascular accidents
Acute respiratory distress syndrome	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
Mechanical Ventilator free days	From icu admission date to icu discharge date an average of 2 weeks	Days without mechanical ventilation
Shock	From icu admission date to icu discharge date an average of 2 weeks	Systolic blood pressure \< 90 mmHg
Surgery revision	From icu admission date to icu discharge date an average of 2 weeks	Surgical re exploration
ICU stay	From icu admission date to icu discharge date an average of 2 weeks	Duration of intensive care stay
Vasopressor	From icu admission date to icu discharge date an average of 2 weeks	Use of vasopressors as norepinephrine and epinephrine
Hospital stay	From icu admission date to icu discharge date an average of 2 weeks	Duration of hospital stay
Mortality	From icu admission date to icu discharge date an average of 2 weeks	Death of patient

Trial Locations

Locations (1)

Aswan university hospital; 🇪🇬 Aswan, Egypt