Critical Ill PatientsNCT04383171
Looking at the Physiological Response of Ergometry in Critical Care Patients
An observational study of Critical Ill Patients, run by University Hospital Southampton NHS Foundation Trust.
Trial summary
Exploring the physiological and metabolic demands of passive ergometry in the critical ill patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Ill Patients
- What is being tested?
- Motomed cycle ergometer (MOTOmed letto2 - Reck, Reckstr 1-5, Betzenweiler 88422, Germany).
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2015to 7 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult patients admitted to the Intensive Care Unit with a medical diagnosis and requiring intubation and ventilation for at least 48 hours and on the Early Mobility Programme (EMP) within 72 hours of admission.
Who may be able to join
- already on the Early Mobility Programme (EMP)
- cardiovascularly stable (stable vasopressor dose for two hours)
- stable heart rate (<140 bpm) and heart rhythm
- presence of a jugular central venous pressure (CVP) line and arterial line.
Who cannot join
- prior rapidly deteriorating neuromuscular disease
- upper limb problem precluding cycle ergometry
- pyrexia (temp >38 °C)
- raised intracranial pressure
- poor prognostic outcomes
- lack of agreement from clinician
- Next of kin/Legal representative (NOK/LR) not understanding English.
About this study
Official title: A Prospective Observational Cohort Study - Does Early Limb Ergometry Affect Oxygen Delivery and Uptake in Intubated Critically Ill Patients?
Exploring the physiological and metabolic demands of passive ergometry in the critical ill patient.
Read the detailed description
This study explores the physiological and metabolic demands of passive ergometry as a step in active rehabilitation and compares two methods of monitoring these changes in critically ill patients.
- Conditions
- Critical Ill Patients
- Being tested
- Motomed cycle ergometer (MOTOmed letto2 - Reck, Reckstr 1-5, Betzenweiler 88422, Germany).
- Keywords
- Early rehabilitation, Physiological response, Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motomed cycle ergometer (MOTOmed letto2 - Reck, Reckstr 1-5, Betzenweiler 88422, Germany).Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological demands of early passive ergometry use in the critically ill patient.
Haemodynamic measurements collected were arterial systolic and diastolic blood pressure (SBP/DBP mmHg).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Haemodynamic measurements collected were heart rate (HR beats/min).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Haemodynamic measurements collected were cardiac output (CO L/min).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demandsof early passive ergometry use in the critically ill patient.
Respiratory measurements collected were stroke volume (SV m/L).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Respiratory measurements collected were respiratory rate (RR breaths/min).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Respiratory measurements collected were minute volume (MV L/min) and tidal volume (VT L/min).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Metabolic measurements collected were oxygen delivery (DO2 m/L) and oxygen uptake (VO2 m/L).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Metabolic measurements collected were central venous oxygen saturation (ScvO2 %).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Metabolic measurements collected were CO2 production (VCO2 mL/min).
Measured: Minute by minute measurements were taken over the 60 minute data collection period.
Physiological demands of early passive ergometry use in the critically ill patient.
Paired venous and arterial blood gas samples were collected.
Measured: These were taken every 10 minutes over the 60 minute data collection period.
Secondary outcomes (1)
Comparing two methods of measuring oxygen uptake (VO2 mL/min) and oxygen delivery (DO2 mL/min) during one passive ergometry session in the critically ill patient.
Oxygen uptake (VO2) was calculated by two methods.
- Method one calculated VO2 with the value of CO from the LiDCO™ using the modified technique of the Fick equation using paired central mixed venous and arterial blood gas samples: VO2 mL/min = CO x (CaO2 - CvO2) x10.
- Method two calculated VO2 by the E-COVX metabolic module via the ventilator from the value of fraction of inspired O2 (FiO2), expiratory minute volume (MV), expired concentrations of O2 (FeO2) and CO2 (FeCO2) using the equation: VO2 ml/min= MV (FiO2 -FeO2 - FiO2 (FeCO2))/1-FiO2.
Measured: Minute by minute haemodynamic and metabolic measurements were taken over the 60 minute data collection period. Paired venous and arterial blood gas samples were taken every 10 minutes over the 60 minute data collection period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start17 Mar 2015
- Primary completion7 Jun 2017
- Study completion7 Jun 2017
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 Critical Ill PatientsStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383171
- Sponsor's protocol ID
- southamptonNHSTrust
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Wilkinson OM, Bates A, Cusack R. An observational feasibility study - does early limb ergometry affect oxygen delivery and uptake in intubated critically ill patients - a comparison of two assessment methods. BMC Anesthesiol. 2021 Jan 25;21(1):27. doi: 10.1186/s12871-020-01227-z.
PubMed 33494702
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study - Does Early Limb Ergometry Affect Oxygen Delivery and Uptake in Intubated Critically Ill Patients?
- ClinicalTrials.gov ID
- NCT04383171
- Acronym / sponsor ID
- southamptonNHSTrust
- Conditions
- Critical Ill Patients
- Keywords
- Early rehabilitation, Physiological response, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 12 May 2020 (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.
Exploring the physiological and metabolic demands of passive ergometry in the critical ill patient.
Detailed description
This study explores the physiological and metabolic demands of passive ergometry as a step in active rehabilitation and compares two methods of monitoring these changes in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult patients admitted to the Intensive Care Unit with a medical diagnosis and requiring intubation and ventilation for at least 48 hours and on the Early Mobility Programme (EMP) within 72 hours of admission.
Key inclusion criteria (4 listed)
- already on the Early Mobility Programme (EMP)
- cardiovascularly stable (stable vasopressor dose for two hours)
- stable heart rate (<140 bpm) and heart rhythm
- presence of a jugular central venous pressure (CVP) line and arterial line.
Key exclusion criteria (7 listed)
- prior rapidly deteriorating neuromuscular disease
- upper limb problem precluding cycle ergometry
- pyrexia (temp >38 °C)
- raised intracranial pressure
- poor prognostic outcomes
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 |
|---|---|---|
| Motomed cycle ergometer (MOTOmed letto2 - Reck, Reckstr 1-5, Betzenweiler 88422, Germany). | Device | – |
Primary outcome
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Haemodynamic measurements collected were arterial systolic and diastolic blood pressure (SBP/DBP mmHg).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Haemodynamic measurements collected were heart rate (HR beats/min).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Haemodynamic measurements collected were cardiac output (CO L/min).
Physiological demandsof early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Respiratory measurements collected were stroke volume (SV m/L).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Respiratory measurements collected were respiratory rate (RR breaths/min).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Respiratory measurements collected were minute volume (MV L/min) and tidal volume (VT L/min).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Metabolic measurements collected were oxygen delivery (DO2 m/L) and oxygen uptake (VO2 m/L).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Metabolic measurements collected were central venous oxygen saturation (ScvO2 %).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: Minute by minute measurements were taken over the 60 minute data collection period.
Metabolic measurements collected were CO2 production (VCO2 mL/min).
Physiological demands of early passive ergometry use in the critically ill patient.
Time frame: These were taken every 10 minutes over the 60 minute data collection period.
Paired venous and arterial blood gas samples were collected.
1 secondary outcome
Comparing two methods of measuring oxygen uptake (VO2 mL/min) and oxygen delivery (DO2 mL/min) during one passive ergometry session in the critically ill patient.
Time frame: Minute by minute haemodynamic and metabolic measurements were taken over the 60 minute data collection period. Paired venous and arterial blood gas samples were taken every 10 minutes over the 60 minute data collection period.
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 12 May 2020.
- Derived from this study: PubMed 33494702Wilkinson OM, Bates A, Cusack R. An observational feasibility study - does early limb ergometry affect oxygen delivery and uptake in intubated critically ill patients - a comparison of two assessment methods. BMC Anesthesiol. 2021 Jan 25;21(1):27. doi: 10.1186/s12871-020-01227-z.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Ill Patients, run by University Hospital Southampton NHS Foundation Trust.
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 4 inclusion and 7 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Physiological demands of early passive ergometry use in the critically ill patient. (time frame: Minute by minute measurements were taken over the 60 minute data collection period.). The study lists 10 primary outcomes in all. 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 NCT04383171, 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 12 May 2020.