Looking at the Physiological Response of Ergometry in Critical Care Patients

Sponsor
University Hospital Southampton NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04383171
Collaborator
(none)
12
26.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Motomed cycle ergometer (MOTOmed letto2 - Reck, Reckstr 1-5, Betzenweiler 88422, Germany).

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

Study Type:
Observational
Actual Enrollment :
12 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Observational Cohort Study - Does Early Limb Ergometry Affect Oxygen Delivery and Uptake in Intubated Critically Ill Patients?
Actual Study Start Date :
Mar 17, 2015
Actual Primary Completion Date :
Jun 7, 2017
Actual Study Completion Date :
Jun 7, 2017

Outcome Measures

Primary Outcome Measures

  1. Physiological demands of early passive ergometry use in the critically ill patient. [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. [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. [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. [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. [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. [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. [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. [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. [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. [These were taken every 10 minutes over the 60 minute data collection period.]

    Paired venous and arterial blood gas samples were collected.

Secondary Outcome Measures

  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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital Southampton NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04383171
Other Study ID Numbers:
  • southamptonNHSTrust
First Posted:
May 12, 2020
Last Update Posted:
May 12, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by University Hospital Southampton NHS Foundation Trust

Study Results

No Results Posted as of May 12, 2020