Is high oxygen concentration a riskfactor for postoperative complications? A prospective, randomized singel blinded study in elderly patients undergoing vascular surgery

Is high oxygen concentration a riskfactor for postoperative complications? A prospective, randomized, singel blinded study in elderly patients undergoing vascular surgery

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001584-36-SE

Enrollment

Unknown

Registered

2016-04-14

Start date

2016-06-01

Completion date

Unknown

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective vascular surgery (peripheral vascular and aortic surgery)

Interventions

Trade Name: Medicinsk Oxygen AGA Product Name: Syrgas Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: OXYGEN Other descriptive name: OXYGEN Concentration unit: % percent Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients undergoing elective vascular surgery on arteries (peripheral vascular and aortic surgery). Elective surgery means that there is no medical need for surgery within 24 hours. - > 65 years old - No language or communication difficulties - Willing to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: Patients with chronic obstructive pulmonary disease or other lung diseases that require oxygen therapy at rest. Patients undergoing carotid surgery Patients scoring < 24p on the preoperative MMT (when applicable)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Composite morbidity / mortality 600 or treatment requiring * Stroke / TIA in unity with international definition * Renal insufficiency: RIFLE criteria with at least doubling of creatinine / urea, or a decrease in GFR> 50% or urine production 4 units e-conc / 24t) * Deep vein thrombosis / pulmonary embolism: clinical suspicion and radiological diagnosis * Other complications that are considered by the investigator as serious or delays time to departure from hospital * Re-hospitalization due to complications * Deaths within 30 days ;Main Objective: Can a high oxygen concentration in inhaled air result in increased morbidity /mortality< 30 days in patients undergoing vascular surgeries?;Secondary Objective: Is there a correlation between postoperative cognitive dysfunction in elderly and inspired oxygen concentration? Have increased reactive oxygen species (ROS) production during elevated oxygen supply any impact on morbidity? Can a low content of antioxidants in blood contribute to increased risk of perioperative complications during oxygen supply? ;Timepoint(s) of evaluation of this end point: < 30 days after vascular surgery	—

Measure

Time frame

Primary end point(s): Composite morbidity / mortality 600 or treatment requiring * Stroke / TIA in unity with international definition * Renal insufficiency: RIFLE criteria with at least doubling of creatinine / urea, or a decrease in GFR> 50% or urine production 4 units e-conc / 24t) * Deep vein thrombosis / pulmonary embolism: clinical suspicion and radiological diagnosis * Other complications that are considered by the investigator as serious or delays time to departure from hospital * Re-hospitalization due to complications * Deaths within 30 days ;Main Objective: Can a high oxygen concentration in inhaled air result in increased morbidity /mortality< 30 days in patients undergoing vascular surgeries?;Secondary Objective: Is there a correlation between postoperative cognitive dysfunction in elderly and inspired oxygen concentration? Have increased reactive oxygen species (ROS) production during elevated oxygen supply any impact on morbidity? Can a low content of antioxidants in blood contribute to increased risk of perioperative complications during oxygen supply? ;Timepoint(s) of evaluation of this end point: < 30 days after vascular surgery

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Secondary

Measure	Time frame
Secondary end point(s): Cytokine concentration (several pro- and anti-inflammatory cytokines are measured in blood and peritoneal fluid) Total ROS production in blood Cognitive dysfunction Plasma antioxidant concentration Time to discharge Other complications between 30 days -1 years after surgery.;Timepoint(s) of evaluation of this end point: Blood samples will be taken preoperatively and postoperatively after 4, 24 and 48 hours Cognitive function tests will be performed pre-operatively and postoperatively after 24 hours, 7 days and 30 days. Postoperative complications between 30 days - 1 year after surgery.	—

Measure

Time frame

Secondary end point(s): Cytokine concentration (several pro- and anti-inflammatory cytokines are measured in blood and peritoneal fluid) Total ROS production in blood Cognitive dysfunction Plasma antioxidant concentration Time to discharge Other complications between 30 days -1 years after surgery.;Timepoint(s) of evaluation of this end point: Blood samples will be taken preoperatively and postoperatively after 4, 24 and 48 hours Cognitive function tests will be performed pre-operatively and postoperatively after 24 hours, 7 days and 30 days. Postoperative complications between 30 days - 1 year after surgery.

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Countries

Sweden

Contacts

Public ContactANIVA-kliniken, USÖ

Universitetssjukhuset Örebro, USÖ

+4619602 10 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026