Hemodynamic Repercussions of Noninvasive Ventilation

Haemodynamic Rebound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139631
• Other study ID #: 070490
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: September 13, 2015
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Haemodynamic Rebound

Intervention

Other:
• Noninvasive ventilation
Assess the hemodynamic repercussions of the positive end expiratory pressure applied noninvasively

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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;11 — View 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. — View 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. — View Citation

Pinsky MR. Heart lung interactions during mechanical ventilation. Curr Opin Crit Care. 2012 Jun;18(3):256-60. doi: 10.1097/MCC.0b013e3283532b73. Review. — View Citation

Schmidt GA. Cardiopulmonary interactions in acute lung injury. Curr Opin Crit Care. 2013 Feb;19(1):51-6. doi: 10.1097/MCC.0b013e32835c35ac. Review. — View Citation

Steingrub JS, Tidswell M, Higgins TL. Hemodynamic consequences of heart-lung interactions. J Intensive Care Med. 2003 Mar-Apr;18(2):92-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference between the hemodynamic effects generated by ventilation modes CPAP and Bilevel		3 hours	Yes
Primary	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	Yes
Secondary	Measurement of cardiac output as a predictor of cardiopulmonary adaptation to different pressures.		5 minutes	Yes