Critical IllnessPOSDOTNCT02999932
Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy
A study testing SpO2 directed oxygen therapy in people with Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 13 sites in China.
Trial summary
Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the mortality in patients staying longer than 72 hours in ICUs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- SpO2 directed oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,706 participants
- Where
- 13 sitesChina
- Study dates
- 1 May 2019to 29 May 2022
- 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
- aged 18 years or older and admitted into ICU, with expected stay in ICU more than 72 hours or longer.
Who cannot join
- under 18 years old, expected stay in ICU less than 72 hours, unconsented inclusion, ICU readmission, patients with acute exacerbation of chronic obstruction disease, patients with severe acute respiratory distress syndrome (defined as PaO2/FiO2 ≤ 100mmHg and PEEP ≥10cmH2O), decision to withhold life-sustaining treatment, physician forgetting to screen during 12 hours after admission, pregnancy, patients with acute myocardial infarction, paraquat poisoning and patients on extracorporeal membrane oxygenation (ECMO) or planned to be on ECMO.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Department of critical care medicine，Luoyang Central Hospital Affiliated to ZhengZhou University
Luoyang, Henan, 471000
Department of critical care medicine, Renmin Hospital of Shiyan City
Shiyan, Hubei, 442000
Department of critical care medicine, Taihe Hospital
Shiyan, Hubei, 442000
Department of critical care medicine, The Central Hospital of Wuhan
Wuhan, Hubei, 430000
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Department of critical care medicine，Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Intensive Care Unit, Hubei Cancer Hospital
Wuhan, Hubei, 430079
Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine
Xiangyang, Hubei, 441000
Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Xiangyang, Hubei, 441021
Department of critical care medicine，Xinyang Central Hospital
Xinyang, Henan, 464000
Department of critical care medicine, Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Department of critical care medicine，Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450007
About this study
Official title: Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients
Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the mortality in patients staying longer than 72 hours in ICUs.
Read the detailed description
In fear of harmful effect of hypoxia, oxygen therapy is commonly used, especially in critically ill patients in intensive care units (ICUs). However, hyperoxia can be harmful too. Examples are myocardial infarction (MI) patients and patients resuscitated to return of spontaneous circulation after cardiac arrest. In Air Versus Oxygen in Myocardial Infarction (AVOID) trial, Meyhoff and colleagues proved hyperoxia caused more cardiac injury in patients with ST-elevation MI but without hypoxia. Kilgannon and colleagues found that arterial hyperoxia following resuscitation from cardiac arrest were associated with increased in-hospital mortality, and a pulse oxygen saturation (SpO2) of 94-98% was recommended.
Recently, Panwar and colleagues found that compared to liberal oxygen strategy (SpO2 ≥96%), conservative oxygen strategy (SpO2 of 88%-92%) was feasible in patients receiving invasive mechanical ventilation. Girardis and colleagues found control oxygen therapy (targeting SpO2 of 94%-98% or PaO2 of 70-100mmHg) resulted lower ICU mortality than conventional oxygen therapy (SpO2 ≥97%) in the randomized clinical trial called Oxygen-ICU. However, the Oxygen-ICU trial was single-centered, early-terminated with only 480 patients included and led to an unplanned interim analysis. In this larger multicenter trial, investigators hypothesized that a relative low SpO2 directed oxygen therapy was safe and would reduced the 28-day mortality in patients staying longer than 72 hours in ICUs.
- Conditions
- Critical Illness
- Being tested
- SpO2 directed oxygen therapy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpO2 directed oxygen therapyOther
Oxygen therapy was administered to achieve targeted SpO2.
| Study group | Role | What they receive |
|---|---|---|
| Low SpO2 group | Experimental | SpO2 90-95%, with FiO2 as low as possible. Receives: Other: SpO2 directed oxygen therapy |
| High SpO2 group | Active comparator | SpO2 96-100%, with FiO2 no lower than 30%. Receives: Other: SpO2 directed oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Death within 28 days after inclusion
Measured: 28 days
Secondary outcomes (2)
ventilator-free time
Hours free from ventilator
Measured: 14 days
RRT-free time
Hours free from renal replacment therapy
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start1 May 2019
- Primary completion1 May 2022
- Study completion29 May 2022
Why it stopped: Slow inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 1,706 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Principal investigator, Xiaobo Yang, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Shiying Yuan, MD, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999932
- Sponsor's protocol ID
- WuhanUHICU201701
- Acronym
- POSDOT
- Status last verified
- Sep 2022
- First submitted
- 14 Dec 2016
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02999932
- Acronym / sponsor ID
- POSDOT / WuhanUHICU201701
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow inclusion
- Enrolment
- 1,706 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 29 May 2022 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the mortality in patients staying longer than 72 hours in ICUs.
Detailed description
In fear of harmful effect of hypoxia, oxygen therapy is commonly used, especially in critically ill patients in intensive care units (ICUs). However, hyperoxia can be harmful too. Examples are myocardial infarction (MI) patients and patients resuscitated to return of spontaneous circulation after cardiac arrest. In Air Versus Oxygen in Myocardial Infarction (AVOID) trial, Meyhoff and colleagues proved hyperoxia caused more cardiac injury in patients with ST-elevation MI but without hypoxia. Kilgannon and colleagues found that arterial hyperoxia following resuscitation from cardiac arrest were associated with increased in-hospital mortality, and a pulse oxygen saturation (SpO2) of 94-98% was recommended.
Recently, Panwar and colleagues found that compared to liberal oxygen strategy (SpO2 ≥96%), conservative oxygen strategy (SpO2 of 88%-92%) was feasible in patients receiving invasive mechanical ventilation. Girardis and colleagues found control oxygen therapy (targeting SpO2 of 94%-98% or PaO2 of 70-100mmHg) resulted lower ICU mortality than conventional oxygen therapy (SpO2 ≥97%) in the randomized clinical trial called Oxygen-ICU. However, the Oxygen-ICU trial was single-centered, early-terminated with only 480 patients included and led to an unplanned interim analysis. In this larger multicenter trial, investigators hypothesized that a relative low SpO2 directed oxygen therapy was safe and would reduced the 28-day mortality in patients staying longer than 72 hours in ICUs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low SpO2 group | Experimental | Other: SpO2 directed oxygen therapySpO2 90-95%, with FiO2 as low as possible. |
| High SpO2 group | Active comparator | Other: SpO2 directed oxygen therapySpO2 96-100%, with FiO2 no lower than 30%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 years or older and admitted into ICU, with expected stay in ICU more than 72 hours or longer.
Key exclusion criteria (1 listed)
- under 18 years old, expected stay in ICU less than 72 hours, unconsented inclusion, ICU readmission, patients with acute exacerbation of chronic obstruction disease, patients with severe acute respiratory distress syndrome (defined as PaO2/FiO2 ≤ 100mmHg and PEEP ≥10cmH2O), decision to withhold life-sustaining treatment, physician forgetting to screen during 12 hours after admission, pregnancy, patients with acute myocardial infarction, paraquat poisoning and patients on extracorporeal membrane oxygenation (ECMO) or planned to be on ECMO.
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 |
|---|---|---|
| SpO2 directed oxygen therapyOxygen therapy was administered to achieve targeted SpO2. | Other | High SpO2 group, Low SpO2 group |
Primary outcome
28-day mortality
Time frame: 28 days
Death within 28 days after inclusion
2 secondary outcomes
ventilator-free time
Time frame: 14 days
RRT-free time
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Slow inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Shiying Yuan, MD study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpO2 directed oxygen therapy in people with Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 13 sites in China.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. 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. 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 was stopped early (reason given: Slow inclusion). Results are not available in the source record.
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?
28-day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2023.