Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in Post-Operative Cardiac Surgery

December 12, 2017 updated by: Alita Paula Lopes de Novaes, Universidade Federal de Pernambuco

Use of Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in the Post-Operative Cardiac Surgery: Controlled and Randomized Clinical Trial

NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and atelectasis. Noninvasive ventilation has been used to prevent and treat such complications. Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation and pulmonary ventilation. OBJECTIVE: To compare the effects of non-invasive ventilation with oxygen therapy in cardiac post-operative patients. MATERIALS AND METHODS: It will be a randomized controlled clinical trial where patients will be divided into two groups: a group that will perform NIV for 1 hour and the group that will only use oxygen therapy. They will be evaluated through Electrical Impedance Tomography and arterial gasometry analysis just before extubation, soon after extubation, during the intervention and after the intervention for a period of 2 hours after extubation. EXPECTED RESULTS: It is expected that the NIV group will present higher pulmonary ventilation and aeration and better gas exchange than the oxygen therapy group, and that the time of therapeutic effect will be higher in the NIV group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The proposal basically consists of Validation of the hypothesis: The use of Non-invasive Ventilation in patients in the postoperative cardiac surgery results in greater ventilation, greater aeration, and improved gas exchange when compared to the oxygen therapy group.

The use of noninvasive ventilation in the postoperative cardiac surgery has been widely used in clinical practice, but the evidence of the benefits of this technique in this population in relation to some criteria have not yet been elucidated in the scientific literature, such as the effect of NIV in ventilation and pulmonary ventilation, and how long does this effect last.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wagner Leite, specialist
  • Phone Number: +5581981410170

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50751380
        • Recruiting
        • Alita Paula Lopes de Novaes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Immediate postoperative period of cardiac surgery
  • age between 18 and 65 years
  • BMI between 18.5 and 30 kg / m2
  • Patients still intubated when admitted to the ICU
  • without previous history of severe pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, or chronic renal failure, or associated neuromuscular diseases

Exclusion Criteria:

  • Patients considered to be at risk for extubation failure (hypercapnia, more than failure in the autonomic test, AVM time greater than 72 hours, ineffective cough)
  • Cardiopulmonary bypass time more than 150 minutes
  • Hemodynamic instability (arrhythmias, cardiogenic shock, severe hypotension with SBP <90mmHg)
  • Episodes of abdominal distension, nausea and vomiting
  • Hypoxemia (PO2 <50mmHg with FiO2 50%) or hypercapnia (PaCO2> 55mmHg with pH <7.30)
  • Patients who are at high surgical risk according to Euroscore II

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group VNI 1h
Intervention: Non invasive ventilation, applied for 1 hour
Device: Non invasive ventilation
Non invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway.
No Intervention: Group O2
Oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in electrical impedance measures
Time Frame: data recorded 5 minutes before extubation, 5 minutes after extubation, at the first 5 minutes of therapy, 25 to 30 minutes after beginning of therapy, 55 to 60 minutes after beginning of therapy, and 1,5 hour and 2 hours after beginning of therapy
impedance variation data recorded by impedance electrical tomography
data recorded 5 minutes before extubation, 5 minutes after extubation, at the first 5 minutes of therapy, 25 to 30 minutes after beginning of therapy, 55 to 60 minutes after beginning of therapy, and 1,5 hour and 2 hours after beginning of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Blood gases analysis - PaO2 (mmHg), PaCO2 (mmHg), PaO2/FiO2
Time Frame: recorded 5 minutes before extubation and 1 hour after extubation
Collected by a Laboratory professional
recorded 5 minutes before extubation and 1 hour after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Investigators

  • Study Director: Daniella C Brandão, PhD, UFPE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2017

Primary Completion (Actual)

December 12, 2017

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Tomografia de Impedância

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Datas relative to the results of the use of electrical impedance tomography, besides blood gases and vital signs.

IPD Sharing Time Frame

march 2018

IPD Sharing Access Criteria

Date will be available by a USB pen drive copy by the researchers, including date relative to electrical impedance tomography and to bloog gases

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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