Clinical trial NCT04383171: Looking at the Physiological Response of Ergometry in Critical Care Patients
Official title: A Prospective Observational Cohort Study - Does Early Limb Ergometry Affect Oxygen Delivery and Uptake in Intubated Critically Ill Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Ill Patients
Keywords: Early rehabilitation
Physiological response
Critical care
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demandsof early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: Minute by minute measurements were taken over the 60 minute data collection period.
measure: Physiological demands of early passive ergometry use in the critically ill patient.
timeFrame: These were taken every 10 minutes over the 60 minute data collection period.
Secondary outcomes:
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.