Impaired Oxygen DeliveryNCT03355118
Oxygen Extraction and Delivery in Elderly During Major Surgery
An observational study of Impaired Oxygen Delivery and Surgery, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Impaired Oxygen Delivery, Surgery, Postoperative Complications
- What is being tested?
- General anaesthesia and major surgery
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 27 Nov 2017to 4 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Men and women ≥65 years undergoing major/complex surgical procedures at the Karolinska University Hospital in Huddinge, Stockholm
Who may be able to join
- Men and women aged ≥65 years
- Major/complex surgery (BUPA AXA classification of surgical severity)
- Central and arterial venous catheterization for hemodynamic monitoring.
- Written informed consent
- Available research team for the measurements If two subjects are eligible the elder one will be chosen. If there are two subjects eligible of different gender and almost the same age, the subject with a gender that is underrepresented by two or more will be chosen. This is consistent with the purpose of including subjects with as high age as possible without interfering with recruitment.
Who cannot join
- Concomitant medication with Lithium (interferes with calibration of the LiDCO monitor)
- Weight≤ 40 kg.
- Not possible to establish arterial or central venous line.
- Planned postoperative care at high-dependency unit (POP/IMA) <12hrs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring New Grounds in Physiology of the Elderly- Oxygen Extraction and Delivery During Anaesthesia and Major Surgery
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.
Read the detailed description
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.
- Being tested
- General anaesthesia and major surgery
- Medical subject headings
- Postoperative Complications, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anaesthesia and major surgeryOther
The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption
change of oxygen consumption after anaesthesia induction
Measured: prior to and 15 minutes after anaesthesia induction
Secondary outcomes (6)
oxygen consumption
changes of oxygen consumption during surgery and postoperative recovery
Measured: perioperatively 0-36hrs
oxygen extraction ratio
ratio between oxygen consumption and oxygen delivery
Measured: 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
Measured: perioperatively 0-36hrs
C(v-a)pCO2/C(a-v)O2
Ratio: venoarterial pCO2 difference/arterio-venous oxygen content difference
Measured: perioperatively 0-36hrs
postoperative complications
postoperative complications described by Postoperative Morbidity Survey (8)
Measured: postoperative days 3,5 and 10
mortality
postoperative mortality
Measured: postoperative days 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start27 Nov 2017
- Primary completion23 Mar 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Oxygen DeliveryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigridur Kalman, Karolinska Institutet
- Investigators
- Erzsebet Bartha, MD PhD, Study director, Karolinska University Hospital Huddinge, Stockholm, SwedenJulia Jakobsson, MD, Principal investigator, Karolinska University Hospital Huddinge, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355118
- Sponsor's protocol ID
- K2017-0373
- Other IDs
- 4-500/2017
- Status last verified
- Jun 2022
- First submitted
- 22 Nov 2017
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32858583
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring New Grounds in Physiology of the Elderly- Oxygen Extraction and Delivery During Anaesthesia and Major Surgery
- ClinicalTrials.gov ID
- NCT03355118
- Acronym / sponsor ID
- K2017-0373
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Men and women ≥65 years undergoing major/complex surgical procedures at the Karolinska University Hospital in Huddinge, Stockholm
Key inclusion criteria (5 listed)
- Men and women aged ≥65 years
- Major/complex surgery (BUPA AXA classification of surgical severity)
- Central and arterial venous catheterization for hemodynamic monitoring.
- Written informed consent
- Available research team for the measurements If two subjects are eligible the elder one will be chosen. If there are two subjects eligible of different gender and almost the same age, the subject with a gender that is underrepresented by two or more will be chosen. This is consistent with the purpose of including subjects with as high age as possible without interfering with recruitment.
Key exclusion criteria (4 listed)
- Concomitant medication with Lithium (interferes with calibration of the LiDCO monitor)
- Weight≤ 40 kg.
- Not possible to establish arterial or central venous line.
- Planned postoperative care at high-dependency unit (POP/IMA) <12hrs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anaesthesia and major surgeryThe effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome | Other | – |
Primary outcome
oxygen consumption
Time frame: prior to and 15 minutes after anaesthesia induction
change of oxygen consumption after anaesthesia induction
6 secondary outcomes
oxygen consumption
Time frame: perioperatively 0-36hrs
oxygen extraction ratio
Time frame: perioperatively 0-36hrs
oxygen extraction ratio: estimated and measured
Time frame: perioperatively 0-36hrs
C(v-a)pCO2/C(a-v)O2
Time frame: perioperatively 0-36hrs
postoperative complications
Time frame: postoperative days 3,5 and 10
mortality
Time frame: postoperative days 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 32858583Jakobsson 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erzsebet Bartha, MD PhD study director
Karolinska University Hospital Huddinge, Stockholm, Sweden
Julia Jakobsson, MD principal investigator
Karolinska University Hospital Huddinge, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Oxygen Delivery and Surgery, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen consumption (time frame: prior to and 15 minutes after anaesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03355118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.