Hemodynamic Repercussions of Noninvasive Ventilation

NCT02139631 | Completed DMC

• 1 other identifier: 070490
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemodynamic Rebound

Keywords

hemodynamic; mechanical ventilation; respiration with positive pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of cardiac output as a predictor of cardiopulmonary adaptation to different pressures.

  5 minutes

Other Outcomes (1)

• Difference between the hemodynamic effects generated by ventilation modes CPAP and Bilevel

  3 hours

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

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

Interventions

Noninvasive ventilation OTHER

Assess the hemodynamic repercussions of the positive end expiratory pressure applied noninvasively

Also known as: Continuos positive airway pressure, Bilevel, Positive end expiratory pressure

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals
• Age between 18 and 40 years old
• Non smoker

You may not qualify if:

• Clinical signs or symptoms of any disease decompensation
• History of blood pressure variations by autonomic dysfunction
• Sense of claustrophobia
• Smoker

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Location

Related Publications (6)

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

  PMID: 22473256 RESULT

• 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.

  PMID: 7042203 RESULT

• 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.

  PMID: 7005679 RESULT

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

  PMID: 23201585 RESULT

• 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.

  PMID: 9726745 RESULT

• 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.

  PMID: 15189655 RESULT

MeSH Terms

Interventions

Noninvasive Ventilation; Continuous Positive Airway Pressure; Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Celia R Lopes

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Avaliação das repercussões hemodinâmicas com o uso de ventilação mecânica não invasiva em indivíduos saudáveis por meio do ecodopplercardiograma

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

BR (1)