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
About this trial
This is an interventional diagnostic trial for Atelectasis
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
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
NCT ID
NCT03211936
First Posted
April 20, 2017
Last Updated
September 18, 2017
Sponsor
Instituto do Cancer do Estado de São Paulo
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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