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Completed

NCT Number: NCT03141216

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Real Português de Beneficência em Pernambuco

Recife, Pernambuco, 52010-040, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

VCV+PSV

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.

Other names: volume controlled ventilation mode, pressure support ventilation mode

PCV+PSV

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.

Other names: pressure controlled ventilation mode, pressure support mode

Primary outcomes

  1. electrical impedance measures

    Time frame: 5 minutes of recording at each step of mechanical ventilation progression before extubation.

    impedance variation data recorded by a tomograph.

Secondary outcomes

  1. arterial gas blood analysis data

    Time frame: up to 12h, following routine care while patients are mechanically ventilated

    measures of pH, PaCO2 (mmHg), PaO2 (mmHg), PaO2/FiO2

  2. patient-ventilator synchrony

    Time frame: 5 minutes of recording at each step of mechanical ventilation progression before extubation

    events of discomfort between patient and ventilator: ineffective efforts and auto-triggering. Expressed in present or ausent.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Collaborators

  • Real Hospital Português de Beneficência em Pernambuco

Registry information

Official study title

Effects of Mechanical Ventilation on Controlled Volume, Controlled Pressure and Pressure Support in the Immediate Postoperative Period of Cardiac Surgery on Pulmonary Electrical Impedance and Patient-ventilator Asynchrony: a Parallel Clinical Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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