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

NCT ID: NCT02562781

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2021-01-31

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%).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Supplemental Oxygen

Inspired oxygen fraction \> 0.5 and SpO2 = 98-100%

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: DRUG

Oxygen in sufficient quantity to maintain SpO2 \> 98%

Air

Intervention Type: OTHER

Supplemental Oxygen in sufficient quantity to maintain SpO2 \> 90%

Air or supplemental oxygen

Air or lowest possible inspired concentration of oxygen to maintain SpO2 \> 90%

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: DRUG

Oxygen in sufficient quantity to maintain SpO2 \> 98%

Air

Intervention Type: OTHER

Supplemental Oxygen in sufficient quantity to maintain SpO2 \> 90%

Interventions

Oxygen

Oxygen in sufficient quantity to maintain SpO2 \> 98%

Intervention Type: DRUG

Air

Supplemental Oxygen in sufficient quantity to maintain SpO2 \> 90%

Intervention Type: OTHER

Other Intervention Names

Medical oxygen; Medical Air

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Anil Gupta

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anil Gupta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

University Hospital

Örebro, , Sweden

Örebro University Hospital

Örebro, , Sweden

Countries

Sweden

Other Identifiers

ÖrebroU

Identifier Type: -

Identifier Source: org_study_id