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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211936
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Tracking Information
First Submitted Date  ICMJE April 20, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date September 20, 2017
Actual Study Start Date  ICMJE December 15, 2015
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
Hyperdistension [ Time Frame: during tritiate peep ]
We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
Atelectasis [ Time Frame: in the final of the procedure ]
After the procedure we analyze with patient group have more atelectasis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulmonary Evaluation With Ultrasound in Different Levels of PEEP
Official Title  ICMJE Pulmonary Evaluation at Different Levels of PEEP: Ultrasonography Compared to Electrical Impedance Tomography (TIE) During Intraoperative Elective Surgeries
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Atelectasis
  • Hypertension
  • Lung Edema
Intervention  ICMJE
  • Procedure: PEEP TITRATED
    After titrated peep levels, we choice this level of peep for de group (peep titrated)
  • Device: Use ultrasound
    We make a lung ultrasound after we setup a different level of PEEP
  • Device: Impedance tomography
    We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.
  • Other: Best PEEP for less collapse
    After titrated PEEP levels we setup the best PEEP the according of tomography impedance
  • Other: PEEP 4
    We set the peep level after titrated peep = 4 cmH20.
Study Arms  ICMJE
  • Active Comparator: PEEP 4

    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
    Interventions:
    • Procedure: PEEP TITRATED
    • Device: Use ultrasound
    • Device: Impedance tomography
    • Other: PEEP 4
  • Experimental: PEEP TITRATED

    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
    Interventions:
    • Procedure: PEEP TITRATED
    • Device: Use ultrasound
    • Device: Impedance tomography
    • Other: Best PEEP for less collapse
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 15, 2017
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03211936
Other Study ID Numbers  ICMJE NP 807/15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Instituto do Cancer do Estado de São Paulo
Study Sponsor  ICMJE Instituto do Cancer do Estado de São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Maria Jose Carmona, PhD University of Sao Paulo
Study Director: Claudia Simões, PhD Universiadde de São Paulo/ ICESP
PRS Account Instituto do Cancer do Estado de São Paulo
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP