Hemodynamic Repercussions of Noninvasive Ventilation

Not Applicable

Completed

• Conditions: Haemodynamic Rebound
• Interventions: Other: Noninvasive ventilation

• Registration Number: NCT02139631
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-13
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Noninvasive ventilation	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

Primary Outcome Measures

Name	Time	Method
Hemodynamic repercussions of different levels of positive end expiratory pressure applied noninvasively, measured by echocardiography	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

Name	Time	Method
Measurement of cardiac output as a predictor of cardiopulmonary adaptation to different pressures.	5 minutes

Trial Locations

Locations (1)

Federal University of Uberlandia; 🇧🇷 Uberlandia, Minas Gerais, Brazil