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

NCT ID: NCT04824703

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2023-05-11

Brief Summary

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

Conditions

Oxygen Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conservative oxygen therapy

• 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

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: DRUG

• 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

Liberal oxygen therapy

• 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

Group Type: PLACEBO_COMPARATOR

Oxygen

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Sayed Mohamed Tammam

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aswan university hospital

Aswān, , Egypt

Countries

Egypt

References

Ghazaly HF, Aly AAA, Tammam AS, Hassan MM, Hammad SS, Mahmoud NM, Hemaida TS. Influence of liberal versus conservative oxygen therapies on the hemodynamic parameters of mechanically ventilated patients with sepsis: a randomized clinical trial. BMC Anesthesiol. 2024 Dec 20;24(1):469. doi: 10.1186/s12871-024-02838-6.

Reference Type: DERIVED

PMID: 39707209 (View on PubMed)

Other Identifiers

Aswu/460/5/20

Identifier Type: -

Identifier Source: org_study_id