Clincosm LogoSign in Get a demo

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

Sponsor
Universidade Federal de Pernambuco (Other)
Overall Status
Completed
CT.gov ID
NCT03141216
Collaborator
Real Hospital Português de Beneficência em Pernambuco (Other)
19
Enrollment
1
Location
2
Arms
9.8
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VCV+PSV
  • Device: PCV+PSV
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Mar 9, 2017
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • volume controlled ventilation mode
  • pressure support ventilation mode

    		•
    Experimental: 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.

    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.
    Other Names:
  • pressure controlled ventilation mode
  • pressure support mode

    		•

    Outcome Measures

    Primary Outcome Measures

    1. electrical impedance measures [5 minutes of recording at each step of mechanical ventilation progression before extubation.]

      impedance variation data recorded by a tomograph.

    Secondary Outcome Measures

    1. arterial gas blood analysis data [up to 12h, following routine care while patients are mechanically ventilated]

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

    2. patient-ventilator synchrony [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Real Português de Beneficência em Pernambuco Recife Pernambuco Brazil 52010-040

    Sponsors and Collaborators

    • Universidade Federal de Pernambuco
    • Real Hospital Português de Beneficência em Pernambuco

    Investigators

    • Principal Investigator: WAGNER S LEITE, Universidade Federal de Pernambuco
    • Study Chair: Shirley Lima Campos, Universidade Federal de Pernambuco

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Wagner Souza Leite, Master's Program student, Universidade Federal de Pernambuco
    ClinicalTrials.gov Identifier:
    NCT03141216
    Other Study ID Numbers:
    • 03021991
    First Posted:
    May 5, 2017
    Last Update Posted:
    Sep 26, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 26, 2019