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| ID | Type | Description | Link |
|---|---|---|---|
| 4-500/2017 | Other Identifier | Karolinska Institutet |
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This clinical observational study investigates perioperative oxygen consumption and delivery in elderly patients undergoing major surgery. The primary objectives are to characterise the perioperative oxygen delivery, consumption and potential markers of oxygen debt. Secondary objective is to estimate the correlation between oxygen delivery/consumption and postoperative outcomes to guide the design of a future trial.
Background Intra- and postoperative fluid therapy aims to achieve or maintain pre-specified thresholds of oxygen delivery/blood flow which can be accomplished by use of fluids with or without inotropic drugs. The used thresholds of oxygen delivery were suggested over 40 years ago, in considerably younger patients compared to the current patients. Update of the characteristics of perioperative oxygen delivery and consumption is reasonable in modern clinical settings.
Primary outcome:
relative changes of oxygen consumption induced by anaesthesia
Secondary outcomes:
relative changes of oxygen consumption and delivery during surgery and postoperatively, oxygen extraction ratio (measured and estimated), potential markers of oxygen debt frequency of in-hospital postoperative complications, mortality (30 Days)
Population:
Men and women ≥65 years undergoing major/complex surgical procedures, when intra-operative cardiovascular monitoring is justified according to clinical decision.
Intervention: no study related intervention, general anaesthesia and surgery according to clinical routine
Blinding: no blinding
Study size:
Pilot study 1: feasibility assessment of study protocol of intra-operative measurements (n= max 10) Pilot study 2: feasibility assessment of study protocol of postoperative measurements (n= max 10) Main study: 60 subjects (20+´40) Planned analysis of oxygen consumption after 20 monitored subjects
Study duration:
Duration of haemodynamic monitoring 24-36 hours Duration of observation of clinical outcomes: 7-10 days, mortality at 30 days postop.
Investigational events:
monitoring of oxygen consumption and delivery monitoring of postoperative clinical outcomes monitoring of markers of tissue injury
Assessments, Procedures and Schedule of Investigational Events:
Subjects are identified by the operation planning list and assessed for eligibility. The study information will be given verbal during the first hospital visit. Subjects who give written informed consent will be included in the study.
Measurements:
oxygen consumption by indirect calorimetry via face mask (in awake state) and via expiratory extension tube of anaesthesia machine (unconscious state) cardiac output monitoring via arterial line (LiDCO) blood samples: arterial and venous blood gase samples, Troponin-T urine samples: N-gal
Clinical outcomes:
Data collection from medical records on postoperative complications using the POMS (postoperative morbidity survey) screening survey at days 3,7 and 10. Postoperative mortality at day 30.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anaesthesia and major surgery | Other | The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome |
| Measure | Description | Time Frame |
|---|---|---|
| oxygen consumption | change of oxygen consumption after anaesthesia induction | prior to and 15 minutes after anaesthesia induction |
| Measure | Description | Time Frame |
|---|---|---|
| oxygen consumption | changes of oxygen consumption during surgery and postoperative recovery | perioperatively 0-36hrs |
| oxygen extraction ratio | ratio between oxygen consumption and oxygen delivery |
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Inclusion Criteria:
Exclusion Criteria
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Men and women ≥65 years undergoing major/complex surgical procedures at the Karolinska University Hospital in Huddinge, Stockholm
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| Name | Affiliation | Role |
|---|---|---|
| Erzsebet Bartha, MD PhD | Karolinska University Hospital Huddinge, Stockholm, Sweden | Study Director |
| Julia Jakobsson, MD | Karolinska University Hospital Huddinge, Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University hospital Huddinge | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32858583 | Derived | Jakobsson J, Noren C, Hagel E, Kalman S, Bartha E. Peri-operative oxygen consumption revisited: An observational study in elderly patients undergoing major abdominal surgery. Eur J Anaesthesiol. 2021 Jan;38(1):4-12. doi: 10.1097/EJA.0000000000001302. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D007431 | Intraoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| perioperatively 0-36hrs |
| oxygen extraction ratio: estimated and measured | ratio between oxygen consumption and oxygen delivery estimated from blood gases and measured by indirect calorimetry and cardiac output monitoring | perioperatively 0-36hrs |
| C(v-a)pCO2/C(a-v)O2 | Ratio: venoarterial pCO2 difference/arterio-venous oxygen content difference | perioperatively 0-36hrs |
| postoperative complications | postoperative complications described by Postoperative Morbidity Survey (8) | postoperative days 3,5 and 10 |
| mortality | postoperative mortality | postoperative days 30 |