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Completed

NCT Number: NCT04383171

Looking at the Physiological Response of Ergometry in Critical Care Patients

Exploring the physiological and metabolic demands of passive ergometry in the critical ill patient.

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Key information

Conditions

Critical Ill Patients

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motomed cycle ergometer (MOTOmed letto2 - Reck, Reckstr 1-5, Betzenweiler 88422, Germany).

Device

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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 %).

  9. 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).

  10. 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.

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.

    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.

    • 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.

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study title

A Prospective Observational Cohort Study - Does Early Limb Ergometry Affect Oxygen Delivery and Uptake in Intubated Critically Ill Patients?

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 12, 2020
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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