Critical IllnessNCT02163109
Oxygen Consumption in Critical Illness
An observational study of Critical Illness, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients requiring intubation and mechanical ventilation on an adult intensive care unit
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Univerity Hospital NHS Trust, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
John D Young, DM, 01865220621, duncan.young@nda.ox.ac.uk
Matthew C Frise, BMBCh, 01865282357, matthew.frise@dpag.ox.ac.uk
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Critical Illness
- Keywords
- Oxygen consumption, Pulmonary gas exchange, Cardiac output
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption
Within patient oxygen consumption over time correlated with changes in physiological variables and treatment received
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startSep 2015
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- John D Young, DM, Principal investigator, University of Oxford and Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163109
- Sponsor's protocol ID
- 14/EE/0003
- Status last verified
- May 2018
- First submitted
- 9 Jun 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cummings B, Hamilton ML, Ciaffoni L, Pragnell TR, Peverall R, Ritchie GA, Hancock G, Robbins PA. Laser-based absorption spectroscopy as a technique for rapid in-line analysis of respired gas concentrations of O2 and CO2. J Appl Physiol (1985). 2011 Jul;111(1):303-7. doi: 10.1152/japplphysiol.00119.2011. Epub 2011 Apr 21.
PubMed 21512147Shoemaker WC, Appel PL, Kram HB. Hemodynamic and oxygen transport responses in survivors and nonsurvivors of high-risk surgery. Crit Care Med. 1993 Jul;21(7):977-90. doi: 10.1097/00003246-199307000-00010.
PubMed 8319478Hayes MA, Timmins AC, Yau EH, Palazzo M, Hinds CJ, Watson D. Elevation of systemic oxygen delivery in the treatment of critically ill patients. N Engl J Med. 1994 Jun 16;330(24):1717-22. doi: 10.1056/NEJM199406163302404.
PubMed 7993413Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169ProCESS Investigators; Yealy DM, Kellum JA, Huang DT, Barnato AE, Weissfeld LA, Pike F, Terndrup T, Wang HE, Hou PC, LoVecchio F, Filbin MR, Shapiro NI, Angus DC. A randomized trial of protocol-based care for early septic shock. N Engl J Med. 2014 May 1;370(18):1683-93. doi: 10.1056/NEJMoa1401602. Epub 2014 Mar 18.
PubMed 24635773Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988 Dec;94(6):1176-86. doi: 10.1378/chest.94.6.1176.
PubMed 3191758
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Oxygen Consumption in Critical Illness Using Optical Gas Analysis
- ClinicalTrials.gov ID
- NCT02163109
- Acronym / sponsor ID
- 14/EE/0003
- Conditions
- Critical Illness
- Keywords
- Oxygen consumption, Pulmonary gas exchange, Cardiac output
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Jun 2014 (estimated)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring intubation and mechanical ventilation on an adult intensive care unit
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxygen consumption
Time frame: Up to 48 hours
Within patient oxygen consumption over time correlated with changes in physiological variables and treatment received
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Background: PubMed 21512147Cummings B, Hamilton ML, Ciaffoni L, Pragnell TR, Peverall R, Ritchie GA, Hancock G, Robbins PA. Laser-based absorption spectroscopy as a technique for rapid in-line analysis of respired gas concentrations of O2 and CO2. J Appl Physiol (1985). 2011 Jul;111(1):303-7. doi: 10.1152/japplphysiol.00119.2011. Epub 2011 Apr 21.
- Background: PubMed 8319478Shoemaker WC, Appel PL, Kram HB. Hemodynamic and oxygen transport responses in survivors and nonsurvivors of high-risk surgery. Crit Care Med. 1993 Jul;21(7):977-90. doi: 10.1097/00003246-199307000-00010.
- Background: PubMed 7993413Hayes MA, Timmins AC, Yau EH, Palazzo M, Hinds CJ, Watson D. Elevation of systemic oxygen delivery in the treatment of critically ill patients. N Engl J Med. 1994 Jun 16;330(24):1717-22. doi: 10.1056/NEJM199406163302404.
- Background: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Background: PubMed 24635773ProCESS Investigators; Yealy DM, Kellum JA, Huang DT, Barnato AE, Weissfeld LA, Pike F, Terndrup T, Wang HE, Hou PC, LoVecchio F, Filbin MR, Shapiro NI, Angus DC. A randomized trial of protocol-based care for early septic shock. N Engl J Med. 2014 May 1;370(18):1683-93. doi: 10.1056/NEJMoa1401602. Epub 2014 Mar 18.
- Background: PubMed 3191758Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988 Dec;94(6):1176-86. doi: 10.1378/chest.94.6.1176.
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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.
John D Young, DM principal investigator
University of Oxford and Oxford University Hospitals NHS Trust
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 Critical Illness, run by University of Oxford at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 8 May 2018. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John D Young, DM (01865220621, duncan.young@nda.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (time frame: Up to 48 hours). 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 NCT02163109, which also lists 6 linked publications.
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 8 May 2018; AzTrials last refreshed its copy on 29 Oct 2026.