Hemodynamic Repercussions of Noninvasive Ventilation

NCT ID: NCT02139631

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Haemodynamic Rebound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Noninvasive ventilation

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Continuos positive airway pressure Bilevel Positive end expiratory pressure

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gabrielle Silva Vinhal

Avaliação das repercussões hemodinâmicas com o uso de ventilação mecânica não invasiva em indivíduos saudáveis por meio do ecodopplercardiograma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Celia R Lopes

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type RESULT
PMID: 22473256 (View on PubMed)

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.

Reference Type RESULT
PMID: 7042203 (View on PubMed)

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.

Reference Type RESULT
PMID: 7005679 (View on PubMed)

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

Reference Type RESULT
PMID: 23201585 (View on PubMed)

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.

Reference Type RESULT
PMID: 9726745 (View on PubMed)

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.

Reference Type RESULT
PMID: 15189655 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

070490

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.