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CompletedNCT02139631Updated Sep 15, 2015

Hemodynamic Repercussions of Noninvasive Ventilation

An interventional study of Noninvasive ventilation in Haemodynamic Rebound, sponsored by Federal University of Uberlandia. Completed at 1 site in Brazil. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Federal University of Uberlandia · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

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Conditions studied

  • Haemodynamic Rebound

Keywords

  • hemodynamic
  • mechanical ventilation
  • respiration with positive pressure
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In context

Lead sponsor

Federal University of Uberlandia is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • OtherNoninvasive ventilation

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

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

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What researchers measure

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

    Time frame: 5 minutes

Secondary outcomes

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

    Time frame: 5 minutes

Other outcomes

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

    Time frame: 3 hours

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Study locations

1 site
  • Federal University of Uberlandia
    Uberlandia, Minas Gerais, Brazil
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References and documents

Publications

  • Pinsky MR. Heart lung interactions during mechanical ventilation. Curr Opin Crit Care. 2012 Jun;18(3):256-60. doi: 10.1097/MCC.0b013e3283532b73. PubMed 22473256 ↗
  • 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. PubMed 7042203 ↗
  • 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. PubMed 7005679 ↗
  • Schmidt GA. Cardiopulmonary interactions in acute lung injury. Curr Opin Crit Care. 2013 Feb;19(1):51-6. doi: 10.1097/MCC.0b013e32835c35ac. PubMed 23201585 ↗
  • 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. PubMed 9726745 ↗
  • 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. PubMed 15189655 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02139631
Lead sponsor
Federal University of Uberlandia
Responsible party
Gabrielle Silva Vinhal (Avaliação das repercussões hemodinâmicas com o uso de ventilação mecânica não invasiva em indivíduos saudáveis por meio do ecodopplercardiograma, Federal University of Uberlandia) — Principal investigator
First posted
May 15, 2014
Start date
May 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Sep 15, 2015

Study contacts

Celia R Lopes
principal investigator · Federal University of Uberlandia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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