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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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

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

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

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)

March 17, 2015

Primary Completion (Actual)

June 7, 2017

Study Completion (Actual)

June 7, 2017

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID 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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