Vascular DiseasePhase 3HYPEROXIANCT02562781
Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications?
A Phase 3 study testing Oxygen and Air in people with Vascular Disease, run by Örebro University, Sweden at 2 sites in Sweden.
Trial summary
Patients undergoing vascular surgery are at a significantly high risk of perioperative cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery. This could be because of co-morbidities that are common in this patient group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vascular Disease
- What is being tested?
- Oxygen and Air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesSweden
- Study dates
- Nov 2014to Jan 2021
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients undergoing elective vascular surgery (peripheral or aortic surgery),
- No language or cognitive disability
- Written, informed consent
Who cannot join
- Patients with COPD/other lung diseases that require preoperative oxygen therapy
- Patients undergoing carotid artery surgery
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital
Örebro, 701 85
Örebro University Hospital
Örebro, 70185
About this study
Official title: Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications? A Randomised, Prospective Study in Patients Undergoing Vascular Surgery
Patients undergoing vascular surgery are at a significantly high risk of perioperative cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery. This could be because of co-morbidities that are common in this patient group. Additionally, smoking, which is common in this population, may be a contributing factor.
Oxygen therapy has been used for decades in order to reduce the risk of myocardial infarction and stroke in patients undergoing vascular surgery and pre-existing co-morbidities in the belief that increased inspired oxygen increases oxygen delivery to tissues, thereby reducing the risk for hypoxia and cell death. However, several studies published recently have questioned the routine use of high inspired oxygen concentration (hyperoxia) to improve oxygen delivery, specifically in the neonatal period but possibly even following myocardial infarction. This could be explained by the fact that increasing inspired concentrations of oxygen cause vasoconstriction in cerebral and coronary arteries, thereby reducing blood flow. Additionally, increased oxygen causes excessive production of reactive oxygen species (ROS), and repercussion injury from oxidative stress. The latter can lead to apoptosis (cell death) in myocardial or cerebral neurons. Despite the high risks of administering oxygen when not needed, it is routinely used in hospitals all over the world without a doctors prescription.
This study aims to assess peri-operative complications up to 1 year following vascular surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2 98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).
Read the detailed description
Oxygen is probably one of the commonest "non-prescription" drug used in the hospital and its advantage in several situations including carbon monoxide poisoning, central hypoxia and prior to planned intubation in an acute situation are today well-established and commonly used. Oxygen has been frowned upon in the resuscitation of newborn babies because of the risk of retrolental hypoplasia, now well accepted and adopted in clinical practice. Oxygen has also been traditionally used to increase oxygen carrying capacity in patients presenting with an acute coronary syndrome (ACS), to reduce surgical site infections (SSI), to ensure adequate oxygen delivery to tissues in unconscious patients, during cardiac surgery and for postoperative management, specifically after major surgery. Thus, deliberate use of high inspiratory oxygen concentrations (e.g., 80% or above) is recommended in the treatment of specific intoxications, such as with carbon monoxide or cyanide, wherein hyperbaric oxygen should also be considered. In addition, a high oxygen fraction has been suggested to prevent adverse outcomes after surgery and anesthesia, including a reduction in wound infections and postoperative nausea and vomiting (PONV). In critically ill patients, oxygen delivery to the tissues is often compromised, and supplemental oxygen (e.g., face mask with 10 L oxygen per min) is commonly administered to patients with pneumonia, sepsis, acute coronary syndrome, or stroke - in fact, it is estimated that oxygen is given during transport in approximately one-third of all ambulance journeys.
Several reports published recently have questioned many of the "routine" uses of oxygen and some evidence even seems to point towards negative outcomes in some of these conditions. Specifically, excessive oxygen is likely to do more harm than good in the neonatal period, following cardio-pulmonary resuscitation and likely following acute myocardial infarction. Prospective, randomised studies on this important use of oxygen in the preoperative string are, however, lacking in the literature and in view of theoretical risks for hyperoxemia to several organs, the routine use of high oxygen fractions during the peri-operative phase can be questioned.
This study aims to assess peri-operative complications up to 1 year following vascular surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2 98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).
- Conditions
- Vascular Disease
- Being tested
- Oxygen, Air
- Keywords
- postoperative complications, postoperative cognitive dysfunction, oxygen
- Medical subject headings
- Vascular Diseases, Postoperative Complications, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Also called Medical oxygen
Oxygen in sufficient quantity to maintain SpO2 > 98%
AirOther
Also called Medical Air
Supplemental Oxygen in sufficient quantity to maintain SpO2 > 90%
| Study group | Role | What they receive |
|---|---|---|
| Supplemental Oxygen | Active comparator | Inspired oxygen fraction > 0.5 and SpO2 = 98-100% Receives: Drug: Oxygen; Other: Air |
| Air or supplemental oxygen | Experimental | Air or lowest possible inspired concentration of oxygen to maintain SpO2 > 90% Receives: Drug: Oxygen; Other: Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite morbidity
Major complications such as MACE, TIA/stroke/renal insufficiency/POCD etc
Measured: 0 - 1 month postoperatively
Secondary outcomes (4)
Long term outcome (Major complications)
Major complications
Measured: 1 month to 1 year postoperatively
Specific outcomes (Major adverse cardiac events (MACE))
Major adverse cardiac events (MACE)
Measured: 0 - 1 year postoperatively
Specific outcomes (TIA or stroke)
TIA or stroke
Measured: 0 - 1 year postoperatively
Specific outcomes (renal insufficiency including dialysis or renal failure)
renal insufficiency including dialysis or renal failure
Measured: 0 - 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Gupta, Örebro University, Sweden
- Investigators
- Anil Gupta, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562781
- Sponsor's protocol ID
- ÖrebroU
- Acronym
- HYPEROXIA
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2014
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications? A Randomised, Prospective Study in Patients Undergoing Vascular Surgery
- ClinicalTrials.gov ID
- NCT02562781
- Acronym / sponsor ID
- HYPEROXIA / ÖrebroU
- Conditions
- Vascular Disease
- Keywords
- postoperative complications, postoperative cognitive dysfunction, oxygen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 29 Sep 2015 (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.
Patients undergoing vascular surgery are at a significantly high risk of perioperative cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery. This could be because of co-morbidities that are common in this patient group. Additionally, smoking, which is common in this population, may be a contributing factor.
Oxygen therapy has been used for decades in order to reduce the risk of myocardial infarction and stroke in patients undergoing vascular surgery and pre-existing co-morbidities in the belief that increased inspired oxygen increases oxygen delivery to tissues, thereby reducing the risk for hypoxia and cell death. However, several studies published recently have questioned the routine use of high inspired oxygen concentration (hyperoxia) to improve oxygen delivery, specifically in the neonatal period but possibly even following myocardial infarction. This could be explained by the fact that increasing inspired concentrations of oxygen cause vasoconstriction in cerebral and coronary arteries, thereby reducing blood flow. Additionally, increased oxygen causes excessive production of reactive oxygen species (ROS), and repercussion injury from oxidative stress. The latter can lead to apoptosis (cell death) in myocardial or cerebral neurons. Despite the high risks of administering oxygen when not needed, it is routinely used in hospitals all over the world without a doctors prescription.
This study aims to assess peri-operative complications up to 1 year following vascular surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2 98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).
Detailed description
Oxygen is probably one of the commonest "non-prescription" drug used in the hospital and its advantage in several situations including carbon monoxide poisoning, central hypoxia and prior to planned intubation in an acute situation are today well-established and commonly used. Oxygen has been frowned upon in the resuscitation of newborn babies because of the risk of retrolental hypoplasia, now well accepted and adopted in clinical practice. Oxygen has also been traditionally used to increase oxygen carrying capacity in patients presenting with an acute coronary syndrome (ACS), to reduce surgical site infections (SSI), to ensure adequate oxygen delivery to tissues in unconscious patients, during cardiac surgery and for postoperative management, specifically after major surgery. Thus, deliberate use of high inspiratory oxygen concentrations (e.g., 80% or above) is recommended in the treatment of specific intoxications, such as with carbon monoxide or cyanide, wherein hyperbaric oxygen should also be considered. In addition, a high oxygen fraction has been suggested to prevent adverse outcomes after surgery and anesthesia, including a reduction in wound infections and postoperative nausea and vomiting (PONV). In critically ill patients, oxygen delivery to the tissues is often compromised, and supplemental oxygen (e.g., face mask with 10 L oxygen per min) is commonly administered to patients with pneumonia, sepsis, acute coronary syndrome, or stroke - in fact, it is estimated that oxygen is given during transport in approximately one-third of all ambulance journeys.
Several reports published recently have questioned many of the "routine" uses of oxygen and some evidence even seems to point towards negative outcomes in some of these conditions. Specifically, excessive oxygen is likely to do more harm than good in the neonatal period, following cardio-pulmonary resuscitation and likely following acute myocardial infarction. Prospective, randomised studies on this important use of oxygen in the preoperative string are, however, lacking in the literature and in view of theoretical risks for hyperoxemia to several organs, the routine use of high oxygen fractions during the peri-operative phase can be questioned.
This study aims to assess peri-operative complications up to 1 year following vascular surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2 98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental Oxygen | Active comparator | Drug: Oxygen, Other: AirInspired oxygen fraction > 0.5 and SpO2 = 98-100% |
| Air or supplemental oxygen | Experimental | Drug: Oxygen, Other: AirAir or lowest possible inspired concentration of oxygen to maintain SpO2 > 90% |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective vascular surgery (peripheral or aortic surgery),
- No language or cognitive disability
- Written, informed consent
Key exclusion criteria (2 listed)
- Patients with COPD/other lung diseases that require preoperative oxygen therapy
- Patients undergoing carotid artery surgery
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 |
|---|---|---|
| OxygenAlso: Medical oxygenOxygen in sufficient quantity to maintain SpO2 > 98% | Drug | Air or supplemental oxygen, Supplemental Oxygen |
| AirAlso: Medical AirSupplemental Oxygen in sufficient quantity to maintain SpO2 > 90% | Other | Air or supplemental oxygen, Supplemental Oxygen |
Primary outcome
Composite morbidity
Time frame: 0 - 1 month postoperatively
Major complications such as MACE, TIA/stroke/renal insufficiency/POCD etc
4 secondary outcomes
Long term outcome (Major complications)
Time frame: 1 month to 1 year postoperatively
Specific outcomes (Major adverse cardiac events (MACE))
Time frame: 0 - 1 year postoperatively
Specific outcomes (TIA or stroke)
Time frame: 0 - 1 year postoperatively
Specific outcomes (renal insufficiency including dialysis or renal failure)
Time frame: 0 - 1 year postoperatively
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 4 Mar 2021.
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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.
Anil Gupta, MD, PhD principal investigator
Örebro University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxygen and Air in people with Vascular Disease, run by Örebro University, Sweden at 2 sites in Sweden.
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 3 inclusion and 2 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite morbidity (time frame: 0 - 1 month postoperatively). 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 4 Mar 2021.