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

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

Study Overview

• Status: Recruiting
• Conditions: Oxygen Therapy
• Intervention / Treatment: Drug: Oxygen

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Tammam; Phone Number: 201027555869; Email: A.temooo85@gmail.com

Study Locations

• Egypt
  • Aswan, Egypt
    • Recruiting
    • Aswan University Hospital
    • Contact: Ahmed Tammam, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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
Placebo Comparator: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute respiratory distress syndrome	Acute persistent hypoxia with bilateral lung infiltrate due to non cardiac cause	From icu admission date to icu discharge date an average of 2 weeks
Sepsis	Systolic blood pressure < 90 Respiratory rate > 22 Heart rate > 100	From icu admission date to icu discharge date an average of 2 weeks
Stroke	Cerebrovascular accidents	From icu admission date to icu discharge date an average of 2 weeks
Mechanical Ventilator free days	Days without mechanical ventilation	From icu admission date to icu discharge date an average of 2 weeks
Shock	Systolic blood pressure < 90 mmHg	From icu admission date to icu discharge date an average of 2 weeks
Surgery revision	Surgical re exploration	From icu admission date to icu discharge date an average of 2 weeks
Vasopressor	Use of vasopressors as norepinephrine and epinephrine	From icu admission date to icu discharge date an average of 2 weeks
ICU stay	Duration of intensive care stay	From icu admission date to icu discharge date an average of 2 weeks
Hospital stay	Duration of hospital stay	From icu admission date to icu discharge date an average of 2 weeks
Mortality	Death of patient	From icu admission date to icu discharge date an average of 2 weeks

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 5, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Oxygen therapy and Mortality
• Other Study ID Numbers: Aswu/460/5/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No