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

NCT03141216 | Completed DMC

• 1 other identifier: 03021991
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• electrical impedance measures

  impedance variation data recorded by a tomograph.

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

Secondary Outcomes (2)

• arterial gas blood analysis data

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

• patient-ventilator synchrony

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

Study Arms (2)

VCV+PSV

EXPERIMENTAL

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

PCV+PSV

EXPERIMENTAL

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

Interventions

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.

Also known as: volume controlled ventilation mode, pressure support ventilation mode

VCV+PSV

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.

Also known as: pressure controlled ventilation mode, pressure support mode

PCV+PSV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Real Hospital Português de Beneficência em Pernambuco: collaborator

Study Sites (1)

Hospital Real Português de Beneficência em Pernambuco

Recife, Pernambuco, 52010-040, Brazil

Location

Related Links

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

Study Officials

• WAGNER S LEITE

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

• Shirley Lima Campos

  Universidade Federal de Pernambuco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Program student

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: May 5, 2017
• Study Start: March 9, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)