Oxygen Consumption in Critical Illness

May 2, 2018 updated by: University of Oxford

Measurement of Oxygen Consumption in Critical Illness Using Optical Gas Analysis

Many serious illnesses are characterised by a lack of oxygen delivery to the body's tissues. This can be due to problems with the circulation, such as when the heart fails to pump blood efficiently or if the blood pressure is very low, or due to changes in the lungs preventing them from transferring oxygen effectively from the air into the blood.

Many of the treatments used in critically ill patients are aimed at improving the supply of oxygen-rich blood to the tissues. These include drugs to increase the blood pressure or make the heart pump more forcibly, blood transfusions to increase the amount of oxygen that the blood can carry, and ventilators (breathing machines) to help the lungs introduce more oxygen into the bloodstream. Decisions to use such treatments are based on a number of factors. One of the most important is an assessment of how much oxygen an individual patient is using at a given time. Whilst it is possible to measure average oxygen consumption over a long period of time in healthy individuals, the equipment and techniques needed are simply not practical for routine use in the clinical setting of a critical care unit. Critical care doctors and nurses therefore have to rely on a number of different indicators of the adequacy of the amount of oxygen that is being provided in order to make decisions about how best to treat patients. Unfortunately, all of these have their limitations, are affected by other treatments patients may be receiving, and can be difficult to interpret. Examples include 'mixed venous oxygen saturation' (SvO2), that is the amount of oxygen in the blood coming back to the lungs from the body, ready to have more oxygen added, and blood lactate levels, which give an indication of whether the tissues have enough oxygen to produce the energy they need to function in an efficient manner.

Our group has developed a device which can be added easily to the normal equipment used on a critical care ward when a patient is on a ventilator, which can accurately and rapidly measure the amount of oxygen the individual is consuming.

This study will provide us with data so the investigators can define a "normal" range of oxygen consumption in these patients, and treatments which alter consumption. In a future study, once the investigators know what the normal range is, they can introduce new techniques to improve oxygen consumption in those patients whose consumption is less than ideal.

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a prospective longitudinal observational study in thirty intubated, ventilated patients. Patients will be recruited from the population of already intubated and ventilated individuals on an adult intensive care unit (AICU). Once patients have been recruited we will insert the optical gas analyser (OGA) into the ventilation circuit (tubing) for 48 hours.

Data will be continuously collected until 48 hours from attachment of the OGA, death or extubation of the patient, and analysed retrospectively. A time series describing oxygen consumption with a resolution of one minute or less will be prepared and standard measures of dispersion calculated. In addition, variables that are routinely recorded on the computerised clinical record during the same period will then be examined and associations sought between these variables and changes in oxygen consumption as measured with the OGA. We have prospectively identified variables which, based on the published literature, are likely to be associated with variation in oxygen consumption (VO2) upon which attention will focus, though others may become apparent during the study:

  • Body temperature
  • Seizures
  • Change in haemoglobin concentration (including due to blood transfusion)
  • Bolus fluids
  • Vasoactive drugs
  • Beta-agonist drugs
  • Drugs affecting the angiotensin-converting enzyme system
  • Renal replacement therapy
  • Feeding
  • Sedation
  • Neuromuscular blockers
  • Mode of ventilation
  • Fraction of inspired oxygen (FiO2)
  • Physical activity
  • Surgery

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford Univerity Hospital NHS Trust, John Radcliffe Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Matthew C Frise, BMBCh
        • Principal Investigator:
          • John D Young, DM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients requiring intubation and mechanical ventilation on an adult intensive care unit

Description

Inclusion Criteria:

  • Male and female patients aged 18 years or over
  • Admitted to an adult intensive care unit
  • Expected duration of intubation and mechanical ventilation of at least 48 hours

Exclusion Criteria:

  • Consultee indicates patient would be likely to decline enrolment
  • Patient is receiving palliative care
  • Use of active cooling
  • Heavy sputum production (or other indication) necessitating use of an active humidifier in ventilator circuit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Critically-ill patients
Adult patients requiring intubation and mechanical ventilation on an intensive care unit, predicted to require a further 48 hours of artificial ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen consumption
Time Frame: Up to 48 hours
Within patient oxygen consumption over time correlated with changes in physiological variables and treatment received
Up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John D Young, DM, University of Oxford and Oxford University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 14/EE/0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critical Illness

3
Subscribe