The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

  • STATUS
    Recruiting
  • End date
    Jun 30, 2021
  • participants needed
    90
  • sponsor
    University of Athens
Updated on 24 January 2021
carbon monoxide
cigarette smoke

Summary

Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG CE marking nMED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

Description

This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.

Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation 10%.

In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG will be assessed by comparison with the reference method consisting in a mass spectrometer.

Details
Condition Smoking Cessation, smoking cessation therapy
Treatment I quit smoking (IQOS), Conventional cigarette, I quit ordinary smoking (IQOS)
Clinical Study IdentifierNCT03452124
SponsorUniversity of Athens
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 60 yrs?
Gender: Male or Female
Do you have Smoking Cessation?
Do you have any of these conditions: smoking cessation therapy or Smoking Cessation?
Active conventional cigarette smoker

Exclusion Criteria

Health condition adversely affected by smoking
History or presence of cardiovascular disease
Clear my responses

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