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

NCT04824703 | Completed

• 1 other identifier: Aswu/460/5/20
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Keywords

Oxygen therapy and Mortality

Outcome Measures

Primary Outcomes (2)

• Change in Stroke volume in milliliters

  Volume of blood in milliliters that is ejected from heart each second and measured By Echocardiography

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

• Change in ejection fraction of heart in percentage

  percentage of blood that's pumped out of a filled ventricle with each heartbeat And measured by echocardiography

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

Secondary Outcomes (10)

• Acute respiratory distress syndrome

  From icu admission date to icu discharge date an average of 2 weeks

• Sepsis

  From icu admission date to icu discharge date an average of 2 weeks

• Stroke

  From icu admission date to icu discharge date an average of 2 weeks

• Mechanical Ventilator free days

  From icu admission date to icu discharge date an average of 2 weeks

• Shock

  From icu admission date to icu discharge date an average of 2 weeks

Study Arms (2)

Conservative oxygen therapy

ACTIVE COMPARATOR

* 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

Drug: Oxygen

Liberal oxygen therapy

PLACEBO COMPARATOR

* 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

Drug: Oxygen

Interventions

Oxygen 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

Conservative oxygen therapy; Liberal oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• severe acute respiratory distress syndrome at time of admission
• acute Chronic obstructive airway disease exacerbation
• pregnancy
• Carbon monoxide poisoning
• Guillain Barre syndrome

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan university hospital

Aswān, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39707209 DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: April 5, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 11, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)