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

April 26, 2024 updated by: Ahmed Sayed Mohamed Tammam, Aswan University Hospital
To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Aswan, Egypt
        • Aswan university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Stroke volume in milliliters
Time Frame: 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
Change from Baseline stroke volume At ICU admission and through study completion An average 6 months
Change in ejection fraction of heart in percentage
Time Frame: 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 from baseline ejection fraction at icu admission and through study completion An Average 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute respiratory distress syndrome
Time Frame: 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
From icu admission date to icu discharge date an average of 2 weeks
Sepsis
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Systolic blood pressure < 90 Respiratory rate > 22 Heart rate > 100
From icu admission date to icu discharge date an average of 2 weeks
Stroke
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Cerebrovascular accidents
From icu admission date to icu discharge date an average of 2 weeks
Mechanical Ventilator free days
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Days without mechanical ventilation
From icu admission date to icu discharge date an average of 2 weeks
Shock
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Systolic blood pressure < 90 mmHg
From icu admission date to icu discharge date an average of 2 weeks
Surgery revision
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Surgical re exploration
From icu admission date to icu discharge date an average of 2 weeks
Vasopressor
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Use of vasopressors as norepinephrine and epinephrine
From icu admission date to icu discharge date an average of 2 weeks
ICU stay
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Duration of intensive care stay
From icu admission date to icu discharge date an average of 2 weeks
Hospital stay
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Duration of hospital stay
From icu admission date to icu discharge date an average of 2 weeks
Mortality
Time Frame: From icu admission date to icu discharge date an average of 2 weeks
Death of patient
From icu admission date to icu discharge date an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aswan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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