Looking at the Physiological Response of Ergometry in Critical Care Patients

NCT04383171 | Completed

• 1 other identifier: southamptonNHSTrust
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Critical Ill Patients

Keywords

Early rehabilitation; Physiological response; Critical care

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 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.

  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.

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Related Publications (1)

• Wilkinson OM, Bates A, Cusack R. An observational feasibility study - does early limb ergometry affect oxygen delivery and uptake in intubated critically ill patients - a comparison of two assessment methods. BMC Anesthesiol. 2021 Jan 25;21(1):27. doi: 10.1186/s12871-020-01227-z.

  PMID: 33494702 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: May 12, 2020
• Study Start: March 17, 2015
• Primary Completion: June 7, 2017
• Study Completion: June 7, 2017
• Last Updated: May 12, 2020

Record last verified: 2019-12