Oxygen Extraction and Delivery in Elderly During Major Surgery

NCT03355118 | Completed

• 2 other identifiers: K2017-03734-500/2017
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. Secondary objective is to estimate the correlation between oxygen delivery/consumption and postoperative outcomes to guide the design of a future trial.

Conditions

Impaired Oxygen Delivery; Surgery; Postoperative Complications; Peroperative Complication

Outcome Measures

Primary Outcomes (1)

• oxygen consumption

  change of oxygen consumption after anaesthesia induction

  prior to and 15 minutes after anaesthesia induction

Secondary Outcomes (6)

• oxygen consumption

  perioperatively 0-36hrs

• oxygen extraction ratio

  perioperatively 0-36hrs

• oxygen extraction ratio: estimated and measured

  perioperatively 0-36hrs

• C(v-a)pCO2/C(a-v)O2

  perioperatively 0-36hrs

• postoperative complications

  postoperative days 3,5 and 10

Interventions

General anaesthesia and major surgery OTHER

The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women ≥65 years undergoing major/complex surgical procedures at the Karolinska University Hospital in Huddinge, Stockholm

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University hospital Huddinge

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32858583 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Intraoperative Complications

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Erzsebet Bartha, MD PhD

  Karolinska University Hospital Huddinge, Stockholm, Sweden

  STUDY DIRECTOR

• Julia Jakobsson, MD

  Karolinska University Hospital Huddinge, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: November 27, 2017
• Primary Completion: March 23, 2018
• Study Completion: April 4, 2018
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

SE (1)