An observational study in Impaired Oxygen Delivery, Surgery and Postoperative Complications, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Karolinska Institutet · Observational
Among 46 studies in Postoperative Complications with a site in Sweden — 10 open to participants now, 14 under way, 1 of them phase 3. Postoperative Complications · Sweden.
Among the 46 studies in Postoperative Complications with a site in Sweden, this one is the 19th largest by enrollment of the 21 observational ones that give a count, is one of 4 that started in 2017, is one of 21 observational ones, and was the 20th registered.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
Browse Postoperative Complications studies →10 of the 46 studies in Postoperative Complications with a site in Sweden are open now. Recruiting first, the newest first:
Uppsala University Hospital · Sites in Sweden
Zealand Pharma · Sites in Sweden, United States, Austria and 11 more countries
Region Skane · Sites in Sweden
Uppsala University · Sites in Sweden
Karolinska University Hospital · Sites in Sweden
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 202 Postoperative Complications studies recruiting now, 126 (62%) set no upper age limit and 32 (16%) stop at 75 or younger; 25 take children under 18; 25 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 4 started in 2017.
This study's enrollment of 20 is below the median of 251 across 537 observational studies indexed under Postoperative Complications.
Median enrollment 150 across the 25 interventional studies, 216 across the 21 observational. Of the 27 that completed or were terminated, 2 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 46 have an industry lead sponsor. The 10 most frequent:
Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Karolinska Institutet has 8 studies filed under Postoperative Complications — fewer than ten, so there is no comparison to draw.
1 of the studies in Postoperative Complications with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05630443Vastra Gotaland RegionEffects of Prone Position After Major Abdominal Surgery | 2026-12-31 |
Among the 46 studies in Postoperative Complications with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Men and women ≥65 years undergoing major/complex surgical procedures at the Karolinska University Hospital in Huddinge, Stockholm
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome
oxygen consumption
change of oxygen consumption after anaesthesia induction
Time frame: prior to and 15 minutes after anaesthesia induction
oxygen consumption
changes of oxygen consumption during surgery and postoperative recovery
Time frame: perioperatively 0-36hrs
oxygen extraction ratio
ratio between oxygen consumption and oxygen delivery
Time frame: 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
Time frame: perioperatively 0-36hrs
C(v-a)pCO2/C(a-v)O2
Ratio: venoarterial pCO2 difference/arterio-venous oxygen content difference
Time frame: perioperatively 0-36hrs
postoperative complications
postoperative complications described by Postoperative Morbidity Survey (8)
Time frame: postoperative days 3,5 and 10
mortality
postoperative mortality
Time frame: postoperative days 30
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Mar 2018, 3 months.
Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 3 months is below that.
Counting every sponsor, half of 281 studies reached it within 23 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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