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Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications? (HYPEROXIA)

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ClinicalTrials.gov Identifier: NCT02562781
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden

Brief 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. 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%).


Condition or disease Intervention/treatment Phase
Vascular Disease Drug: Oxygen Other: Air Phase 3

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%).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications? A Randomised, Prospective Study in Patients Undergoing Vascular Surgery
Study Start Date : November 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Supplemental Oxygen
Inspired oxygen fraction > 0.5 and SpO2 = 98-100%
Drug: Oxygen
Oxygen in sufficient quantity to maintain SpO2 > 98%

Other: Air
Supplemental Oxygen in sufficient quantity to maintain SpO2 > 90%

Experimental: Air or supplemental oxygen
Air or lowest possible inspired concentration of oxygen to maintain SpO2 > 90%
Drug: Oxygen
Oxygen in sufficient quantity to maintain SpO2 > 98%

Other: Air
Supplemental Oxygen in sufficient quantity to maintain SpO2 > 90%




Primary Outcome Measures :
  1. Composite morbidity [ Time Frame: 0 - 1 month postoperatively ]
    Major complications such as MACE, TIA/stroke/renal insufficiency/POCD etc


Secondary Outcome Measures :
  1. Long term outcome (Major complications) [ Time Frame: 1 month to 1 year postoperatively ]
    Major complications

  2. Specific outcomes (Major adverse cardiac events (MACE)) [ Time Frame: 0 - 1 year postoperatively ]
    Major adverse cardiac events (MACE)

  3. Specific outcomes (TIA or stroke) [ Time Frame: 0 - 1 year postoperatively ]
    TIA or stroke

  4. Specific outcomes (renal insufficiency including dialysis or renal failure) [ Time Frame: 0 - 1 year postoperatively ]
    renal insufficiency including dialysis or renal failure


Other Outcome Measures:
  1. Complication (Re-operation or bleeding) [ Time Frame: 0 - 30 days postoperatively ]
    Re-operation or bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective vascular surgery (peripheral or aortic surgery),
  • No language or cognitive disability
  • Written, informed consent

Exclusion Criteria:

  • Patients with COPD/other lung diseases that require preoperative oxygen therapy
  • Patients undergoing carotid artery surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562781


Contacts
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Contact: Anil Gupta, MD, PhD +46 0706561676 anil_guptarca@hotmail.com
Contact: Martin Svahn, MD +46 19 6020000 ext 20307 martin-svahn@orebroll.se

Locations
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Sweden
University Hospital Recruiting
Örebro, Sweden, 701 85
Contact: Anil Gupta, MD,FRCA,PhD    +46 08 51770387    anil.gupta@karolinska.se   
Örebro University Hospital Recruiting
Örebro, Sweden, 70185
Contact: Martin Svahn, MD    +46 19 6020000 ext 20307    martin.svahn@orebroll.se   
Contact: Anil Gupta, MD, PhD    +46 0706561676    anil_guptarca@hotmail.com   
Sponsors and Collaborators
Örebro University, Sweden
Investigators
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Principal Investigator: Anil Gupta, MD, PhD Örebro University, Sweden
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Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02562781    
Other Study ID Numbers: ÖrebroU
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Keywords provided by Anil Gupta, Örebro University, Sweden:
postoperative complications
postoperative cognitive dysfunction
oxygen
Additional relevant MeSH terms:
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Vascular Diseases
Postoperative Complications
Cardiovascular Diseases
Pathologic Processes