Clinical trial NCT02139631: Hemodynamic Repercussions of Noninvasive Ventilation
Official title: Evaluation of the Hemodynamic Repercussions of Non Invasive Ventilation in Healthy Individuals by Doppler Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemodynamic Rebound
Keywords: hemodynamic
mechanical ventilation
respiration with positive pressure
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Hemodynamic repercussions of different levels of positive end expiratory pressure applied noninvasively, measured by echocardiography
timeFrame: 5 minutes
Secondary outcomes:
measure: Measurement of cardiac output as a predictor of cardiopulmonary adaptation to different pressures.
timeFrame: 5 minutes
Other outcomes:
measure: Difference between the hemodynamic effects generated by ventilation modes CPAP and Bilevel
timeFrame: 3 hours
Locations:
city: Uberlandia
country: Brazil
facility: Federal University of Uberlandia
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Celia R Lopes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinsky MR. Heart lung interactions during mechanical ventilation. Curr Opin Crit Care. 2012 Jun;18(3):256-60. doi: 10.1097/MCC.0b013e3283532b73.
citation: Grace MP, Greenbaum DM. Cardiac performance in response to PEEP in patients with cardiac dysfunction. Crit Care Med. 1982 Jun;10(6):358-60. doi: 10.1097/00003246-198206000-00002.
citation: Jardin F, Farcot JC, Boisante L, Curien N, Margairaz A, Bourdarias JP. Influence of positive end-expiratory pressure on left ventricular performance. N Engl J Med. 1981 Feb 12;304(7):387-92. doi: 10.1056/NEJM198102123040703.
citation: Schmidt GA. Cardiopulmonary interactions in acute lung injury. Curr Opin Crit Care. 2013 Feb;19(1):51-6. doi: 10.1097/MCC.0b013e32835c35ac.
citation: Fellahi JL, Valtier B, Beauchet A, Bourdarias JP, Jardin F. Does positive end-expiratory pressure ventilation improve left ventricular function? A comparative study by transesophageal echocardiography in cardiac and noncardiac patients. Chest. 1998 Aug;114(2):556-62. doi: 10.1378/chest.114.2.556.
citation: Steingrub JS, Tidswell M, Higgins TL. Hemodynamic consequences of heart-lung interactions. J Intensive Care Med. 2003 Mar-Apr;18(2):92-9. doi: 10.1177/0885066602250369.