Patient-ventilator Asynchrony in Conventional Ventilation Modes During Short-term Mechanical Ventilation After Cardiac Surgery

NCT ID: NCT03141216

Last Updated: 2019-09-26

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2017-12-31

Brief Summary

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This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate postoperative period on the variables resulting from regional and global pulmonary electrical impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV mode by mechanical ventilator. Half of the participants will receive VCV followed by PSV for weaning, while the other half will receive PCV followed by PSV for weaning.

Detailed Description

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In the immediate postoperative period of cardiac surgery, patients are found under mechanical ventilatory support. Commonly, they are ventilated in controlled and assisted-controlled volume (VCV) or pressure (PCV) modes, with weaning at pressure support (PSV).

Systematic reviews indicate that there is no difference between the VCV and PCV ventilatory modes for some clinical outcomes or that the existing evidence is insufficient. The distribution of regional ventilation and diaphragmatic mobility can be measured from the use of electrical impedance tomography (EIT) and diaphragmatic ultrasonography (US) to clarify the physiological changes and / or mechanisms of adaptation of the organism submitted to controlled modes cycled at volume or at pressure and spontaneously flow cycled mode.

Besides EIT and US measures, gasometric, hemodynamic and respiratory data will also be recorded. The statistical analysis will be considered α≤0.05 for a statistically significant difference.

Conditions

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Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel group study is a simple and commonly used clinical design which compares two treatments. Usually a test therapy is compared with a standard therapy. The allocation of subjects to groups is usually achieved by randomisation. The groups are typically named the treatment group and the control group. Parallel group designs do not require the same number of subjects in each group, although often similar numbers are observed. The design is commonly used in randomised controlled trials. Statistical analysis often boils down to a simple t-test of the between group difference in the outcome, which is usually a mean or a proportion.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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VCV+PSV

volume controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery.

Group Type EXPERIMENTAL

VCV+PSV

Intervention Type DEVICE

invasive mechanical mechanical modes by volume cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.

PCV+PSV

pressure controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery.

Group Type EXPERIMENTAL

PCV+PSV

Intervention Type DEVICE

invasive mechanical mechanical modes by pressure cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.

Interventions

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VCV+PSV

invasive mechanical mechanical modes by volume cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.

Intervention Type DEVICE

PCV+PSV

invasive mechanical mechanical modes by pressure cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.

Intervention Type DEVICE

Other Intervention Names

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volume controlled ventilation mode pressure support ventilation mode pressure controlled ventilation mode pressure support mode

Eligibility Criteria

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Inclusion Criteria

* IMC 18.5-29.9 kg/m²
* Two thoracic tubes (one mediastinal and one left-sided pleural)
* under mechanical ventilation after surgery
* submitted to intraoperative extracorporeal circulation

Exclusion Criteria

* Over 2h of cardiopulmonary bypass
* Over 12h of post-operative mechanical ventilation
* Post-operative bleeding above 500 ml in the first hour or above 300 ml in the first two hours
* History of special conditions (neuromuscular and chronic pulmonary disease, thoracic deformity, abdominal distension).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Real Hospital Português de Beneficência em Pernambuco

UNKNOWN

Sponsor Role collaborator

Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Wagner Souza Leite

Master's Program student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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WAGNER S LEITE

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Shirley Lima Campos

Role: STUDY_CHAIR

Universidade Federal de Pernambuco

Locations

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Hospital Real Português de Beneficência em Pernambuco

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Study Documents

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Document Type: Study Protocol

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View Document

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/24447503

Right ventricular function during one-lung ventilation: effects of pressure-controlled and volume-controlled ventilation

https://www.ncbi.nlm.nih.gov/pubmed/9449727

Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome.

https://www.ncbi.nlm.nih.gov/pubmed/25039666

Tidal ventilation distribution during pressure-controlled ventilation and pressure support ventilation in post-cardiac surgery patients.

https://www.ncbi.nlm.nih.gov/pubmed/9689281

Monitoring perioperative changes in distribution of pulmonary ventilation by functional electrical impedance tomography.

https://www.ncbi.nlm.nih.gov/pubmed/18270359

Refining ventilatory treatment for acute lung injury and acute respiratory distress syndrome.

https://www.ncbi.nlm.nih.gov/pubmed/16283171

Bedside waveforms interpretation as a tool to identify patient-ventilator asynchronies.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216788/

Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation

https://www.ncbi.nlm.nih.gov/pubmed/18753469

Ultrasonographic diagnostic criterion for severe diaphragmatic dysfunction after cardiac surgery.

Other Identifiers

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03021991

Identifier Type: -

Identifier Source: org_study_id

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