Looking at the Physiological Response of Ergometry in Critical Care Patients

Critical Ill Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383171
• Other study ID #: southamptonNHSTrust
• Status: Completed
• Start date: March 17, 2015
• Est. completion date: June 7, 2017

Study information

• Verified date: December 2019
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 7, 2017
• Est. primary completion date: June 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Ill Patients

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	Physiological demands of early passive ergometry use in the critically ill patient.	Haemodynamic measurements collected were heart rate (HR beats/min).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	Physiological demands of early passive ergometry use in the critically ill patient.	Haemodynamic measurements collected were cardiac output (CO L/min).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	Physiological demandsof early passive ergometry use in the critically ill patient.	Respiratory measurements collected were stroke volume (SV m/L).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	Physiological demands of early passive ergometry use in the critically ill patient.	Respiratory measurements collected were respiratory rate (RR breaths/min).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	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).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	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).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	Physiological demands of early passive ergometry use in the critically ill patient.	Metabolic measurements collected were central venous oxygen saturation (ScvO2 %).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	Physiological demands of early passive ergometry use in the critically ill patient.	Metabolic measurements collected were CO2 production (VCO2 mL/min).	Minute by minute measurements were taken over the 60 minute data collection period.
Primary	Physiological demands of early passive ergometry use in the critically ill patient.	Paired venous and arterial blood gas samples were collected.	These were taken every 10 minutes over the 60 minute data collection period.
Secondary	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.	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.