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Hemodynamic Repercussions of Noninvasive Ventilation

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ClinicalTrials.gov Identifier: NCT02139631
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Gabrielle Silva Vinhal, Federal University of Uberlandia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Haemodynamic Rebound Other: Noninvasive ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of the Hemodynamic Repercussions of Non Invasive Ventilation in Healthy Individuals by Doppler Echocardiography
Study Start Date : May 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Healthy volunteers
The volunteers initially underwent a clinical examination, spirometry and echocardiography to prove the health state. Then, different levels of positive end expiratory pressure (PEEP) is applied by the noninvasive ventilation in all individuals and the hemodynamic repercussions are evaluated by the doppler echocardiography
Other: Noninvasive ventilation
Assess the hemodynamic repercussions of the positive end expiratory pressure applied noninvasively
Other Names:
  • Continuos positive airway pressure
  • Bilevel
  • Positive end expiratory pressure




Primary Outcome Measures :
  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 Outcome Measures :
  1. Measurement of cardiac output as a predictor of cardiopulmonary adaptation to different pressures. [ Time Frame: 5 minutes ]

Other Outcome Measures:
  1. Difference between the hemodynamic effects generated by ventilation modes CPAP and Bilevel [ Time Frame: 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139631


Locations
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Brazil
Federal University of Uberlandia
Uberlandia, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
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Principal Investigator: Celia R Lopes Federal University of Uberlandia
Publications of Results:
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Responsible Party: Gabrielle Silva Vinhal, Avaliação das repercussões hemodinâmicas com o uso de ventilação mecânica não invasiva em indivíduos saudáveis por meio do ecodopplercardiograma, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT02139631    
Other Study ID Numbers: 070490
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Gabrielle Silva Vinhal, Federal University of Uberlandia:
hemodynamic
mechanical ventilation
respiration with positive pressure