Oxygen Extraction and Delivery in Elderly During Major Surgery

Surgery Clinical Trial

Official title:

Exploring New Grounds in Physiology of the Elderly- Oxygen Extraction and Delivery During Anaesthesia and Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355118
• Other study ID #: K2017-0373
• Secondary ID: 4-500/2017
• Status: Completed
• Start date: November 27, 2017
• Est. completion date: April 4, 2018

Study information

• Verified date: June 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 4, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Men and women aged =65 years

2. Major/complex surgery (BUPA AXA classification of surgical severity)

3. Central and arterial venous catheterization for hemodynamic monitoring.

4. Written informed consent

5. 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.

Exclusion Criteria

1. Concomitant medication with Lithium (interferes with calibration of the LiDCO monitor)

2. Weight= 40 kg.

3. Not possible to establish arterial or central venous line.

4. Planned postoperative care at high-dependency unit (POP/IMA) <12hrs.

Related Conditions & MeSH terms

• Impaired Oxygen Delivery
• Intraoperative Complications
• Peroperative Complication
• Postoperative Complications
• Surgery

Intervention

Other:
• General anaesthesia and major surgery
The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome

Locations

Country	Name	City	State
Sweden	Karolinska University hospital Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen consumption	change of oxygen consumption after anaesthesia induction	prior to and 15 minutes after anaesthesia induction
Secondary	oxygen consumption	changes of oxygen consumption during surgery and postoperative recovery	perioperatively 0-36hrs
Secondary	oxygen extraction ratio	ratio between oxygen consumption and oxygen delivery	perioperatively 0-36hrs
Secondary	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
Secondary	C(v-a)pCO2/C(a-v)O2	Ratio: venoarterial pCO2 difference/arterio-venous oxygen content difference	perioperatively 0-36hrs
Secondary	postoperative complications	postoperative complications described by Postoperative Morbidity Survey (8)	postoperative days 3,5 and 10
Secondary	mortality	postoperative mortality	postoperative days 30