New Indirect Calorimetry Device for Energy Expenditure Measurement

NCT02024958 | Unknown

• 1 other identifier: ICALIC
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

Energy expenditure (EE) in critically ill patients is highly variable depending on the initial severity of the disease and treatments. Clinicians need to measure EE by indirect calorimetry (IC) to optimize nutritional support. IC devices available on the market have insufficient accuracy for clinical and research use. A new IC is being developed to meet these needs. Objectives: Validation of a reliable and easy-to-use IC device. Primary objective:

• Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC devices in intubated ICU patients on mechanical ventilation Secondary objectives:
• Accuracy of EE measurements in ICU patients of spontaneous breathing
• Accuracy of EE measurement during \~30 min. vs. the sum of 6 periods of 60 min/12 hrs
• Accuracy of EE measurements in ICU patients on non-invasive mechanical ventilation Design: Prospective, controlled, observational multicenter study. Subjects: 182 ICU patients.

Conditions

Acute Respiratory Failure

Keywords

Adult ICU patients; spontaneous breathing; invasive ventilation; non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• calories reference IC devices in intubated ICU patients on mechanical ventilation

  Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC devices in intubated ICU patients on mechanical ventilation

  30 minutes

Secondary Outcomes (3)

• calories

  30 minutes

• calories

  60 minutes

• calories

  30 minutes

Study Arms (1)

indirect calorimetry measurement

Measurement of energy expenditure in made by indirect calorimetry in patients laying down in a supine position on a bed during ongoing measure by connecting the calorimeter to the endotracheal tube (invasive mechanical ventilation) or to the facemask (non-invasive mechanical ventilation), or by using a transparent canopy in plexiglas to cover the head while room-air flows through and is mixed with the expirate (spontaneous breathing). This mixture of patient breath and room air is finally collected and analyzed by the IC device for O2 and CO2 concentrations, and used to calculate EE. EE is calculated using the modified Weir equation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult ICU patients with spontaneous breathing, or on invasive or non-invasive mechanical ventilation admitted into the intesive care unit

You may qualify if:

• Adult ICU patients with spontaneous breathing, or on invasive or non-invasive mechanical ventilation.

You may not qualify if:

• FiO2 \> 60%
• Kidney failure requiring Continous veno-venous hemofiltration (CVVH)
• Conditions promoting air leaks: Positive end-expiratory pressure (PEEP) \>10, Peak ventilatory pressure \> 30
• Chest tube (except if only for liquid drainage = no bubbling)
• Unstable hemodynamic conditions requiring changes in vasoactive drugs either 1 hour before and/or during the IC measurement (i.e. all conditions resulting in unstable pH during IC measurements).
• Change in body temperature \>0.5°C either 1 hr before and/or during the IC measurement
• Physical agitation or curarization either 1 hour before and/or during the IC measurement

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Helse-Bergen HF: collaborator
• University of Lausanne Hospitals: collaborator
• Medical University of Vienna: collaborator
• Rabin Medical Center: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Geneva University Hospital- Nutrition Unit

Geneva, 1211, Switzerland

RECRUITING

Study Officials

• Claude Pichard, Prof

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claude Pichard, Prof

CONTACT

+41 22 372 9349; claude.pichard@unige.ch

Claudia P Heidegger, MD

CONTACT

+41 22 372 7440; claudia-paula.heidegger@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of nutrition

Study Record Dates

• First Submitted: December 28, 2013
• First Posted: December 31, 2013
• Study Start: May 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CH (1)