Hemodynamic Repercussions of Noninvasive Ventilation

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

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.

Study Overview

• Status: Completed
• Conditions: Haemodynamic Rebound
• Intervention / Treatment: Other: Noninvasive ventilation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberlandia, Minas Gerais, Brazil
      • Federal University of Uberlândia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic repercussions of different levels of positive end expiratory pressure applied noninvasively, measured by echocardiography	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	5 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of cardiac output as a predictor of cardiopulmonary adaptation to different pressures.	5 minutes

Other Outcome Measures

Outcome Measure	Time Frame
Difference between the hemodynamic effects generated by ventilation modes CPAP and Bilevel	3 hours

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia

Publications and helpful links

General Publications

• Pinsky MR. Heart lung interactions during mechanical ventilation. Curr Opin Crit Care. 2012 Jun;18(3):256-60. doi: 10.1097/MCC.0b013e3283532b73.
• 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.
• 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.
• Schmidt GA. Cardiopulmonary interactions in acute lung injury. Curr Opin Crit Care. 2013 Feb;19(1):51-6. doi: 10.1097/MCC.0b013e32835c35ac.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (ESTIMATE): May 15, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 15, 2015
• Last Update Submitted That Met QC Criteria: September 13, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: mechanical ventilation; hemodynamic; respiration with positive pressure
• Other Study ID Numbers: 070490