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NCT Number: NCT02139631

Hemodynamic Repercussions of Noninvasive Ventilation

The noninvasive ventilation (NIV) is a method of ventilatory support that does not require artificial airway. Its application is associated with complex hemodynamic repercussions, therefore is important to identify them for safety and effectiveness of the technique application.

The main objective of this research is to evaluate the hemodynamic repercussions using doppler echocardiography in healthy volunteers submitted a different values of positive end expiratory pressure (PEEP) by the following ventilatory modes: Continuous positive airway pressure (CPAP) and Bilevel.

The study hypothesis is that the positive end expiratory pressure (PEEP) may cause hemodynamic repercussions as: reduction of the ventricles pre-load, left ventricle after load, cardiac output and reduction in the diameter of the superior vena cava, due to the increase in the intrathoracic pressure and pulmonary volumes.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals
  • Age between 18 and 40 years old
  • Non smoker

Exclusion criteria

  • Clinical signs or symptoms of any disease decompensation
  • History of blood pressure variations by autonomic dysfunction
  • Sense of claustrophobia
  • Smoker

Treatment and study plan

Noninvasive ventilation

Other

Assess the hemodynamic repercussions of the positive end expiratory pressure applied noninvasively

Other names: Continuos positive airway pressure, Bilevel, Positive end expiratory pressure

Primary outcomes

  1. Hemodynamic repercussions of different levels of positive end expiratory pressure applied noninvasively, measured by echocardiography

    Time frame: 5 minutes

    The hemodynamic variables evaluated are: ventricular preload, left ventricle afterload, cardiac output, blood pressure and the vena cava's diameter. All variables will be assessed by echocardiography

Secondary outcomes

  1. Measurement of cardiac output as a predictor of cardiopulmonary adaptation to different pressures.

    Time frame: 5 minutes

Other outcomes

  1. Difference between the hemodynamic effects generated by ventilation modes CPAP and Bilevel

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

Evaluation of the Hemodynamic Repercussions of Non Invasive Ventilation in Healthy Individuals by Doppler Echocardiography

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 15, 2014
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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