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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03141216
Enrollment
19
Registered
2017-05-05
Start date
2017-03-09
Completion date
2017-12-31
Last updated
2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery

Brief summary

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

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.

Interventions

DEVICEVCV+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.

DEVICEPCV+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.

Sponsors

Real Hospital Português de Beneficência em Pernambuco
CollaboratorUNKNOWN
Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
electrical impedance measures5 minutes of recording at each step of mechanical ventilation progression before extubation.impedance variation data recorded by a tomograph.

Secondary

MeasureTime frameDescription
arterial gas blood analysis dataup to 12h, following routine care while patients are mechanically ventilatedmeasures of pH, PaCO2 (mmHg), PaO2 (mmHg), PaO2/FiO2
patient-ventilator synchrony5 minutes of recording at each step of mechanical ventilation progression before extubationevents of discomfort between patient and ventilator: ineffective efforts and auto-triggering. Expressed in present or ausent.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026