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

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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

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.


Condition or disease Intervention/treatment Phase
Atelectasis Hypertension Lung Edema Procedure: PEEP TITRATED Device: Use ultrasound Device: Impedance tomography Other: Best PEEP for less collapse Other: PEEP 4 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Pulmonary Evaluation at Different Levels of PEEP: Ultrasonography Compared to Electrical Impedance Tomography (TIE) During Intraoperative Elective Surgeries
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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: PEEP 4
We set the peep level after titrated peep = 4 cmH20.

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
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




Primary Outcome Measures :
  1. Hyperdistension [ Time Frame: during tritiate peep ]
    We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension


Secondary Outcome Measures :
  1. Atelectasis [ Time Frame: in the final of the procedure ]
    After the procedure we analyze with patient group have more atelectasis



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211936


Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
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Study Chair: Maria Jose Carmona, PhD University of Sao Paulo
Study Director: Claudia Simões, PhD Universiadde de São Paulo/ ICESP
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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03211936    
Other Study ID Numbers: NP 807/15
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases