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Pulmonary Evaluation With Ultrasound in Different Levels of PEEP (EVALUS)

Primary Purpose

Atelectasis, Hypertension, Lung Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEEP TITRATED
Use ultrasound
Impedance tomography
Best PEEP for less collapse
PEEP 4
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atelectasis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants will be male and female patients, over 18 years of age, who undergo abdominal surgeries (prostatectomies and hysterectomies) and who do not have preexisting pulmonary diseases. They will be approached in the room prior to surgery, at which time the purpose of the research will be explained, besides making clear that it will not entail costs and so little any injury, scar, or damage. If accepted by the patient, the consent form will be applied.

Exclusion Criteria:

  • Exclusion criteria for the study will be: patients classified by the American Society of Anesthesiologists Physical status as ASA-3 or above, patients with obstructive and restrictive respiratory diseases, patients with predictable orotracheal intubation difficulties (eg, obese patients) who require Manipulation of the upper airways. Also excluded are patients with pacemakers and patients scheduled for procedures in the thoracic region

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    PEEP 4

    PEEP TITRATED

    Arm Description

    We titrate peep, using tomography impedance, making ultrasound after "level by level' of peep. After titrated peep we setup peep 4 and maintained during the procedure. PEEP 4 cmH2O Use ultrasound

    We titrate peep, using tomography impedance, making ultrasound after "level by level' of peep. After tritiated peep we setup the best peep for less collapse (using the tomography of electrical impedance) and maintained during the procedure. PEEP titrated Use ultrasound Impedance tomography Best PEEP for less collapse

    Outcomes

    Primary Outcome Measures

    Hyperdistension
    We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension

    Secondary Outcome Measures

    Atelectasis
    After the procedure we analyze with patient group have more atelectasis

    Full Information

    First Posted
    April 20, 2017
    Last Updated
    September 18, 2017
    Sponsor
    Instituto do Cancer do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03211936
    Brief Title
    Pulmonary Evaluation With Ultrasound in Different Levels of PEEP
    Acronym
    EVALUS
    Official Title
    Pulmonary Evaluation at Different Levels of PEEP: Ultrasonography Compared to Electrical Impedance Tomography (TIE) During Intraoperative Elective Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 15, 2015 (Actual)
    Primary Completion Date
    February 15, 2017 (Actual)
    Study Completion Date
    April 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto do Cancer do Estado de São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients submitted to general anesthesia and artificial ventilation almost always develop pulmonary atelectasis, which can determine adverse consequences both intraoperatively and postoperatively. It is recommended to use physiological tidal volume (6 - 8 mL / kg of ideal body weight) during the intraoperative period in order to minimize the risk of lung injury. To prevent the formation of atelectasis, minimizing the risk of complications, the use of PEEP has been recommended. At present, there is no way to make an optimal adjustment of PEEP to the needs of each patient, seeking a value that keeps the alveoli open without forming atelectasis and also without areas of hyperdistension. The aim of this study was to evaluate the agreement between the ultrasound and the electrical impedance tomography - Timpel® (TIE) to detect the beginning of the formation of areas of atelectasis after pulmonary recruitment, with decreasing PEEP values. In addition, the lung ultrasound will be validated for intraoperative use for both adequacy of PEEP, as well as quantitative analyzes of ultrasound images to assess atelectasis. 18 patients (> 18 years) of both sexes, submitted to general anesthesia, will be prospectively studied. All patients will receive, in addition to the usual monitoring, the monitoring with the electrical impedance tomography and chest ultrasonography, after being anesthetized and under neuromuscular block, being ventilated with an inspired fraction of 50% oxygen (or greater to maintain oxygen saturation > 96% ), Tidal volume of 6 mL / kg and respiratory rate to maintain expiratory tidal CO2 between 35-45 cmH2O.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atelectasis, Hypertension, Lung Edema

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEEP 4
    Arm Type
    Active Comparator
    Arm Description
    We titrate peep, using tomography impedance, making ultrasound after "level by level' of peep. After titrated peep we setup peep 4 and maintained during the procedure. PEEP 4 cmH2O Use ultrasound
    Arm Title
    PEEP TITRATED
    Arm Type
    Experimental
    Arm Description
    We titrate peep, using tomography impedance, making ultrasound after "level by level' of peep. After tritiated peep we setup the best peep for less collapse (using the tomography of electrical impedance) and maintained during the procedure. PEEP titrated Use ultrasound Impedance tomography Best PEEP for less collapse
    Intervention Type
    Procedure
    Intervention Name(s)
    PEEP TITRATED
    Intervention Description
    After titrated peep levels, we choice this level of peep for de group (peep titrated)
    Intervention Type
    Device
    Intervention Name(s)
    Use ultrasound
    Intervention Description
    We make a lung ultrasound after we setup a different level of PEEP
    Intervention Type
    Device
    Intervention Name(s)
    Impedance tomography
    Intervention Description
    We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.
    Intervention Type
    Other
    Intervention Name(s)
    Best PEEP for less collapse
    Intervention Description
    After titrated PEEP levels we setup the best PEEP the according of tomography impedance
    Intervention Type
    Other
    Intervention Name(s)
    PEEP 4
    Intervention Description
    We set the peep level after titrated peep = 4 cmH20.
    Primary Outcome Measure Information:
    Title
    Hyperdistension
    Description
    We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension
    Time Frame
    during tritiate peep
    Secondary Outcome Measure Information:
    Title
    Atelectasis
    Description
    After the procedure we analyze with patient group have more atelectasis
    Time Frame
    in the final of the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants will be male and female patients, over 18 years of age, who undergo abdominal surgeries (prostatectomies and hysterectomies) and who do not have preexisting pulmonary diseases. They will be approached in the room prior to surgery, at which time the purpose of the research will be explained, besides making clear that it will not entail costs and so little any injury, scar, or damage. If accepted by the patient, the consent form will be applied. Exclusion Criteria: Exclusion criteria for the study will be: patients classified by the American Society of Anesthesiologists Physical status as ASA-3 or above, patients with obstructive and restrictive respiratory diseases, patients with predictable orotracheal intubation difficulties (eg, obese patients) who require Manipulation of the upper airways. Also excluded are patients with pacemakers and patients scheduled for procedures in the thoracic region
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Jose Carmona, PhD
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Claudia Simões, PhD
    Organizational Affiliation
    Universiadde de São Paulo/ ICESP
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Pulmonary Evaluation With Ultrasound in Different Levels of PEEP

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