Oxygen TherapyNCT04824703
Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients
A study testing Oxygen in people with Oxygen Therapy, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Therapy
- What is being tested?
- Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2021to 11 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults aged 18 years or older admitted to ICU and expected to receive mechanical ventilation beyond next calendar day
- severe acute respiratory distress syndrome at time of admission
- acute Chronic obstructive airway disease exacerbation
- pregnancy
- Carbon monoxide poisoning
- Guillain Barre syndrome
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients
- Conditions
- Oxygen Therapy
- Being tested
- Oxygen
- Keywords
- Oxygen therapy and Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stroke volume in milliliters
Volume of blood in milliliters that is ejected from heart each second and measured By Echocardiography
Measured: 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
Measured: Change from baseline ejection fraction at icu admission and through study completion An Average 6 months
Secondary outcomes (10)
Acute respiratory distress syndrome
Acute persistent hypoxia with bilateral lung infiltrate due to non cardiac cause
Measured: From icu admission date to icu discharge date an average of 2 weeks
Sepsis
Systolic blood pressure < 90 Respiratory rate > 22 Heart rate > 100
Measured: From icu admission date to icu discharge date an average of 2 weeks
Stroke
Cerebrovascular accidents
Measured: From icu admission date to icu discharge date an average of 2 weeks
Mechanical Ventilator free days
Days without mechanical ventilation
Measured: From icu admission date to icu discharge date an average of 2 weeks
Shock
Systolic blood pressure < 90 mmHg
Measured: From icu admission date to icu discharge date an average of 2 weeks
Surgery revision
Surgical re exploration
Measured: From icu admission date to icu discharge date an average of 2 weeks
Vasopressor
Use of vasopressors as norepinephrine and epinephrine
Measured: From icu admission date to icu discharge date an average of 2 weeks
ICU stay
Duration of intensive care stay
Measured: From icu admission date to icu discharge date an average of 2 weeks
Hospital stay
Duration of hospital stay
Measured: From icu admission date to icu discharge date an average of 2 weeks
Mortality
Death of patient
Measured: From icu admission date to icu discharge date an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start5 Apr 2021
- Primary completion5 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygen TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sayed Mohamed Tammam, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824703
- Sponsor's protocol ID
- Aswu/460/5/20
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39707209
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04824703
- Acronym / sponsor ID
- Aswu/460/5/20
- Conditions
- Oxygen Therapy
- Keywords
- Oxygen therapy and Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative oxygen therapy | Active comparator | Drug: 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 | Placebo comparator | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults aged 18 years or older admitted to ICU and expected to receive mechanical ventilation beyond next calendar day
- severe acute respiratory distress syndrome at time of admission
- acute Chronic obstructive airway disease exacerbation
- pregnancy
- Carbon monoxide poisoning
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Conservative oxygen therapy, Liberal oxygen therapy |
Primary outcome
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 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
10 secondary outcomes
Acute respiratory distress syndrome
Time frame: 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
Stroke
Time frame: 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
Shock
Time frame: 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
Vasopressor
Time frame: 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
Hospital stay
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 39707209Ghazaly 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Oxygen Therapy, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stroke volume in milliliters (time frame: Change from Baseline stroke volume At ICU admission and through study completion An average 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.