Looking at the Physiological Response of Ergometry in Critical Care Patients

May 6, 2020 updated by: University Hospital Southampton NHS Foundation Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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.
Time Frame: Minute by minute measurements were taken over the 60 minute data collection period.
Haemodynamic measurements collected were heart rate (HR beats/min).
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.
Time Frame: Minute by minute measurements were taken over the 60 minute data collection period.
Haemodynamic measurements collected were cardiac output (CO L/min).
Minute by minute measurements were taken over the 60 minute data collection period.
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).
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.
Time Frame: Minute by minute measurements were taken over the 60 minute data collection period.
Respiratory measurements collected were respiratory rate (RR breaths/min).
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.
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).
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.
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).
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.
Time Frame: Minute by minute measurements were taken over the 60 minute data collection period.
Metabolic measurements collected were central venous oxygen saturation (ScvO2 %).
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.
Time Frame: Minute by minute measurements were taken over the 60 minute data collection period.
Metabolic measurements collected were CO2 production (VCO2 mL/min).
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.
Time Frame: These were taken every 10 minutes over the 60 minute data collection period.
Paired venous and arterial blood gas samples were collected.
These were taken every 10 minutes over the 60 minute data collection period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.

Oxygen uptake (VO2) was calculated by two methods.

  1. 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.
  2. 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.
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.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Southampton NHS Foundation 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • southamptonNHSTrust

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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