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

Thoracic Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141216
• Other study ID #: 03021991
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2019
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Real Português de Beneficência em Pernambuco	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco	Real Hospital Português de Beneficência em Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electrical impedance measures	impedance variation data recorded by a tomograph.	5 minutes of recording at each step of mechanical ventilation progression before extubation.
Secondary	arterial gas blood analysis data	measures of pH, PaCO2 (mmHg), PaO2 (mmHg), PaO2/FiO2	up to 12h, following routine care while patients are mechanically ventilated
Secondary	patient-ventilator synchrony	events of discomfort between patient and ventilator: ineffective efforts and auto-triggering. Expressed in present or ausent.	5 minutes of recording at each step of mechanical ventilation progression before extubation

External Links

•   Bedside waveforms interpretation as a tool to identify patient-ventilator asynchronies.
•   Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome.
•   Monitoring perioperative changes in distribution of pulmonary ventilation by functional electrical impedance tomography.
•   Refining ventilatory treatment for acute lung injury and acute respiratory distress syndrome.
•   Right ventricular function during one-lung ventilation: effects of pressure-controlled and volume-controlled ventilation
•   Tidal ventilation distribution during pressure-controlled ventilation and pressure support ventilation in post-cardiac surgery patients.
•   Ultrasonographic diagnostic criterion for severe diaphragmatic dysfunction after cardiac surgery.
•   Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation